ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286;

Summary

The FDA issued a Class II for ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN F by Sklar Instruments. Reason: Reports of various packaging issues that may result in a breach of the sterile barrier..

Details

Product Description

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691; 5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414; 6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924; 7) ECONO STERILE STRL ALLIGATOR FCPS 3.5" 25/CS,Model Number 94-5034; 8) ECONO STERILE SERR DRESSING FCP 5 1/2" CS/50,Model Number 94-6146; 9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616; 10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A; 11) ECONO STERILE BALLENGR SPNG FCP SERR7"CS/25,Model Number 96-2289; 12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293; 13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A; 14) ECONO STERILE RUSSIAN TISSUE FCP 6" STER25,Model Number 96-2295A; 15) ECONO STERILE TISSUE FCP 1X2 8" STRL CS/25,Model Number 96-2351; 16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386; 17) ECONO STERILE TUBE OCCL FCP SM STR 7"STER 50,Model Number 96-2406; 18) ECONO STERILE TUBE OCC FCP SM STR 7" STER 25,Model Number 96-2408; 19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410; 20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412; 21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A; 22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M; 23) ECONO STERILE SEMKEN DRESS FCP SERR 5"STER25,Model Number 96-2450M; 24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461; 25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462; 26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A; 27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A; 28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515; 29) ECONO STERILE IRIS FCP 1/2CVD 1x2 STER CS25,Model Number 96-2515A; 30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532; 31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533; 32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A; 33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M; 34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534; 35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A; 36) ECONO STERILE IRIS FCP STR 1X2 4" STER CS/25,Model Number 96-2535A; 37) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536; 38) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536M; 39) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537; 40) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537A; 41) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537M; 42) ECONO STERILE HALSTED FCP CVD 5" STER CS/50,Model Number 96-2538; 43) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539; 44) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539A; 45) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539M; 46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544; 47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545; 48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547; 49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A; 50) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 25,Model Number 96-2548; 51) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 50,Model Number 96-2549; 52) ECONO STERILE CRILE FCP STR 5.5" STERL CS/50,Model Number 96-2550; 53) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551; 54) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551A;

Lot/Code Info: 1) 94-0286, UDI/DI 50649111094406, Lot codes: FSF21; 2) 94-0290, UDI/DI 50649111095045, Lot codes: SK-115; 3) 94-0291, UDI/DI 50649111095144, Lot codes: 824940291, 924940291; 4) 941-0691, UDI/DI 50649111307902, Lot codes: MST8, MST9; 5) 941-1414, UDI/DI 50649111464872, Lot codes: SK-122; 6) 94-1924, UDI/DI 50649111345775, Lot codes: FSF16, FSF22; 7) 94-5034, UDI/DI 50649111040687, Lot codes: SK-112, SK-135; 8) 94-6146, UDI/DI 50649111215535, Lot codes: SK-135; 9) 94-6616, UDI/DI 50649111287457, Lot codes: SK-132; 10) 96-2215A, UDI/DI 50649111487567, Lot codes: HSI; 11) 96-2289, UDI/DI 50649111439986, Lot codes: SK-116; 12) 96-2293, UDI/DI 50649111440012, Lot codes: SK-115, SK-132; 13) 96-2293A, UDI/DI 50649111487598, Lot codes: HSI; 14) 96-2295A, UDI/DI 50649111493254, Lot codes: HST21; 15) 96-2351, UDI/DI 50649111440081, Lot codes: FST21; 16) 96-2386, UDI/DI 50649111440241, Lot codes: FSF18; 17) 96-2406, UDI/DI 50649111035195, Lot codes: FSF18, FSF24, FSF25; 18) 96-2408, UDI/DI 50649111035355, Lot codes: FSF5, FSF12, FSF18, FSF26; 19) 96-2410, UDI/DI 50649111035669, Lot codes: FST9; 20) 96-2412, UDI/DI 50649111035867, Lot codes: FST6, FST9, FST10, FST11, FST12, FST20; 21) 96-2412A, UDI/DI 50649111487550, Lot codes: SK-112; 22) 96-2412M, UDI/DI 50649111027015, Lot codes: 0724962412M; 23) 96-2450M, UDI/DI 50649111464483, Lot codes: 0624962450M; 24) 96-2461, UDI/DI 50649111440432, Lot codes: SK-132; 25) 96-2462, UDI/DI 50649111464490, Lot codes: SK-132; 26) 96-2470A, UDI/DI 50649111487970, Lot codes: SK-112; 27) 96-2472A, UDI/DI 50649111487987, Lot codes: SK-112; 28) 96-2515, UDI/DI 50649111050235, Lot codes: SK-115; 29) 96-2515A, UDI/DI 50649111487857, Lot codes: SK-112; 30) 96-2532, UDI/DI 50649111053212, Lot codes: FSF8, FSF14; 31) 96-2533, UDI/DI 50649111053397, Lot codes: FSF8, FSF11, FSF14, FSF16, FSF17, FSF20, FSF21, FSF22, FSF23; 32) 96-2533A, UDI/DI 50649111487888, Lot codes: HSI; 33) 96-2533M, UDI/DI 50649111215313, Lot codes: SK-116; 34) 96-2534, UDI/DI 50649111478817, Lot codes: FSF15, FSF21, FSF22, FSF23; 35) 96-2534A, UDI/DI 50649111492653, Lot codes: HSF8, HSF18; 36) 96-2535A, UDI/DI 50649111488304, Lot codes: SK-112; 37) 96-2536, UDI/DI 50649111054172, Lot codes: FSF10, FSF21; 38) 96-2536M, UDI/DI 50649111220034, Lot codes: 0724962536M; 39) 96-2537, UDI/DI 50649111054424, Lot codes: FSF5, FSF10; 40) 96-2537A, UDI/DI 50649111219496, Lot codes: SK-112; 41) 96-2537M, UDI/DI 50649111221758, Lot codes: 0724962537M; 42) 96-2538, UDI/DI 50649111054639, Lot codes: FSF10, FSF14, FSF18, FSF20, FSF21, FSF22, FSF23; 43) 96-2539, UDI/DI 50649111054783, Lot codes: FSF5, FSF6, FSF10, FSF12, FSF13, FSF14, FSF18, FSF21, FSF22, FSF24; 44) 96-2539A, UDI/DI 50649111487901, Lot codes: SK-112; 45) 96-2539M, UDI/DI 50649111225336, Lot codes: 0724962539M; 46) 96-2544, UDI/DI 50649111056008, Lot codes: FSF8, FSF10; 47) 96-2545, UDI/DI 50649111056183, Lot codes: FSF10, FSF21; 48) 96-2547, UDI/DI 50649111056497, Lot codes: FSF8, FSF10, FSF13, FSF20, FSF21, FSF22, FSF24, FSF26; 49) 96-2547A, UDI/DI 50649111236417, Lot codes: SK-112, SK-136; 50) 96-2548, UDI/DI 50649111056725, Lot codes: FSF12; 51) 96-2549, UDI/DI 50649111056800, Lot codes: FSF8, FSF17, FSF26; 52) 96-2550, UDI/DI 50649111057135, Lot codes: FSF9, FSF19, FSF22, FSF24; 53) 96-2551, UDI/DI 50649111057234, Lot codes: FSF9, FSF20, FSF24, FSF25; 54) 96-2551A, UDI/DI 50649111487819, Lot codes: SK-112; 55) 96-2552, UDI/DI 50649111057579, Lot codes: FSF13, FSF14, FSF16, FSF21, FSF24; 56) 96-2552M, UDI/DI 50649111400818, Lot codes: SK-133; 57) 96-2553, UDI/DI 50649111057715, Lot codes: FSF5; 58) 96-2554, UDI/DI 50649111057814, Lot codes: SK-134; 59) 96-2555, UDI/DI 50649111057982, Lot codes: FSF19, FSF20, FSF26; 60) 96-2556, UDI/DI 50649111058248, Lot codes: SK-131; 61) 96-2557, UDI/DI 50649111058545, Lot codes: FSF19, FSF26; 62) 96-2558, UDI/DI 50649111058644, Lot codes: SK-131; 63) 96-2559, UDI/DI 50649111058903, Lot codes: SK-115; 64) 96-2559A, UDI/DI 50649111487635, Lot codes: SK-112; 65) 96-2560, UDI/DI 50649111059078, Lot codes: FSF13, FSF14, FSF19, FSF20, FSF21, FSF22, FSF24, FSF25, FSF26; 66) 96-2561, UDI/DI 50649111059290, Lot codes: FSF5, FSF7, FSF8, FSF9, FSF19, FSF20, FSF22, FSF24; 67) 96-2561A, UDI/DI 50649111488007, Lot codes: SK-112; 68) 96-2561M, UDI/DI 50649111259041, Lot codes: 0724962561M; 69) 96-2562, UDI/DI 50649111059511, Lot codes: FSF7, FSF8, FSF11, FSF12, FSF18, FSF19, FSF21, FSF22, FSF26; 70) 96-2563, UDI/DI 50649111059733, Lot codes: FSF5, FSF9, FSF12, FSF14, FSF17, FSF21, FSF22, FSF24; 71) 96-2563A, UDI/DI 50649111487994, Lot codes: SK-112; 72) 96-2563M, UDI/DI 50649111262218, Lot codes: 0724962563M; 73) 96-2566A, UDI/DI 50649111488175, Lot codes: SK-112; 74) 96-2568, UDI/DI 50649111060531, Lot codes: FST13, FST21; 75) 96-2568A, UDI/DI 50649111267558, Lot codes: SK-115; 76) 96-2569, UDI/DI 50649111060715, Lot codes: FST9, FST10, FST21; 77) 96-2569A, UDI/DI 50649111487840, Lot codes: HSI; 78) 96-2570, UDI/DI 50649111060845, Lot codes: SK-115; 79) 96-2570M, UDI/DI 50649111271821, Lot codes: SK-116; 80) 96-2571, UDI/DI 50649111061033, Lot codes: SK-115; 81) 96-2571A, UDI/DI 50649111487642, Lot codes: HSI; 82) 96-2571M, UDI/DI 50649111273498, Lot codes: SK-116; 83) 96-2572, UDI/DI 50649111061187, Lot codes: SK-115; 84) 96-2573, UDI/DI 50649111061408, Lot codes: SK-115, SK-130; 85) 96-2573A, UDI/DI 50649111487758, Lot codes: HSI; 86) 96-2573M, UDI/DI 50649111276697, Lot codes: SK-115, SK-116; 87) 96-2575, UDI/DI 50649111061644, Lot codes: FSF9; 88) 96-2575A, UDI/DI 50649111487789, Lot codes: SK-112; 89) 96-2576, UDI/DI 50649111061897, Lot codes: FSF9; 90) 96-2578, UDI/DI 50649111062375, Lot codes: 724962578; 91) 96-2579, UDI/DI 50649111062542, Lot codes: 724962579; 92) 96-2579M, UDI/DI 50649111285576, Lot codes: 0724962579M; 93) 96-2588, UDI/DI 50649111064096, Lot codes: SK-115; 94) 96-2620, UDI/DI 50649111070493, Lot codes: SK-130; 95) 96-2622, UDI/DI 50649111070851, Lot codes: SK-130, SK-131; 96) 96-2622A, UDI/DI 50649111487802, Lot codes: SK-112; 97) 96-2623A, UDI/DI 50649111488205, Lot codes: SK-112, SK-134; 98) 96-2624, UDI/DI 50649111071209, Lot codes: FSF12, FSF17, FSF18, FSF19, FSF20, FSF22, FSF23, FSF24, FSF25; 99) 96-2624A, UDI/DI 50649111488212, Lot codes: SK-112; 100) 96-2626, UDI/DI 50649111071476, Lot codes: FSF15, FSF22; 101) 96-2653, UDI/DI 50649111076525, Lot codes: FSF8, FSF9, FSF18, FSF20, FSF24; 102) 96-2655, UDI/DI 50649111077027, Lot codes: SK-115; 103) 96-2656, UDI/DI 50649111077072, Lot codes: SK-115; 104) 96-2657, UDI/DI 50649111077232, Lot codes: FSF8, FSF10; 105) 96-2658, UDI/DI 50649111077461, Lot codes: FSF10, FSF17, FSF18, FSF24; 106) 96-2660, UDI/DI 50649111077928, Lot codes: FST10, FST13; 107) 96-2661, UDI/DI 50649111078024, Lot codes: 724962661; 108) 96-2670, UDI/DI 50649111079588, Lot codes: SK-115; 109) 96-2670M, UDI/DI 50649111034556, Lot codes: 0724962670M; 110) 96-2684, UDI/DI 50649111081703, Lot codes: SK-116; 111) 96-2685, UDI/DI 50649111081857, Lot codes: SK-116; 112) 96-2685A, UDI/DI 50649111488038, Lot codes: 60359; 113) 96-2687A, UDI/DI 50649111488311, Lot codes: 60431; 114) 96-2688, UDI/DI 50649111082335, Lot codes: SK-115; 115) 96-2689, UDI/DI 50649111082472, Lot codes: SK-116; 116) 96-2706, UDI/DI 50649111084995, Lot codes: SK-130; 117) 96-2736A, UDI/DI 50649111487918, Lot codes: SK-112; 118) 96-2737A, UDI/DI 50649111488106, Lot codes: SK-112; 119) 96-2738A, UDI/DI 50649111487956, Lot codes: SK-112; 120) 96-2739A, UDI/DI 50649111487963, Lot codes: SK-112, SK-133; 121) 96-2764A, UDI/DI 50649111487871, Lot codes: SK-112; 122) 96-2765, UDI/DI 50649111094185, Lot codes: FST16; 123) 96-2772A, UDI/DI 50649111492585, Lot codes: HSF26; 124) 96-2773A, UDI/DI 50649111492592, Lot codes: SK-133, SK-134; 125) 96-2775, UDI/DI 50649111095793, Lot codes: SK-115; 126) 96-2776A, UDI/DI 50649111492981, Lot codes: SK-115; 127) 96-2777A, UDI/DI 50649111492974, Lot codes: SK-115; 128) 96-2779A, UDI/DI 50649111492967, Lot codes: SK-115; 129) 96-2785A, UDI/DI 50649111488076, Lot codes: HSI; 130) 96-2786A, UDI/DI 50649111488083, Lot codes: HSI; 131) 96-2787A, UDI/DI 50649111488090, Lot codes: HSI; 132) 96-2790A, UDI/DI 50649111488250, Lot codes: SK-112; 133) 96-2791A, UDI/DI 50649111488267, Lot codes: SK-112; 134) 96-2795, UDI/DI 50649111488366, Lot codes: FSF21, FSF24; 135) 96-2921, UDI/DI 50649111120525, Lot codes: FST9; 136) 96-2921A, UDI/DI 50649111480865, Lot codes: HSI; 137) 96-3006, UDI/DI 50649111134720, Lot codes: FSF8, FSF9, FSF26; 138) 96-3010, UDI/DI 50649111135482, Lot codes: FSF21; 139) 96-3015A, UDI/DI 50649111488182, Lot codes: SK-112; 140) 96-3016A, UDI/DI 50649111488199, Lot codes: SK-112; 141) 96-3020A, UDI/DI 50649111493179, Lot codes: HST12; 142) 96-3023A, UDI/DI 50649111493209, Lot codes: HST7; 143) 96-3025A, UDI/DI 50649111493223, Lot codes: HST12; 144) 96-3030A, UDI/DI 50649111492998, Lot codes: SK-134; 145) 96-3558A, UDI/DI 50649111487772, Lot codes: SK-112; 146) 96-3560, UDI/DI 50649111440890, Lot codes: SK-112, SK-131, SK-132; 147) 96-3560A, UDI/DI 50649111487765, Lot codes: SK-112; 148) 96-3566A, UDI/DI 50649111492691, Lot codes: SK-116; 149) 96-3615, UDI/DI 50649111449701, Lot codes: FST10.

Quantity Affected: 245015 units

Reason for Recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-12-03

Company