ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918

Summary

The FDA issued a Class II for ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 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 IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO STERILE OPERATING SCISSOR 5.5" B/B C50,Model Number 94-1346; 5) ECONO STERILE MAYO SCISS STR 5.5" CS/50,Model Number 94-1925; 6) ECONO STERILE OR SCISSORS/FORCEP TRAY 50/CS,Model Number 94-4091; 7) ECONO STERILE WIRE SCISSORS SURGI-OR CS/50,Model Number 94-5692; 8) ECONO STERILE MAYO SCIS STR 6.75" STER CS/50,Model Number 94-6096; 9) ECONO STERILE MAYO SCIS CVD 6.75 STER CS/50,Model Number 94-6097; 10) ECONO STERILE UTILITY SCISS YELL ST CS25 7",Model Number 96-1220; 11) ECONO STERILE UTILITY SCISS ORNG ST CS25 7",Model Number 96-1221; 12) ECONO STERILE UTILITY SCISS PRPL ST CS25 7",Model Number 96-1222; 13) ECONO STERILE UTILITY SCISSOR MAG ST CS25 7",Model Number 96-1224; 14) ECONO STERILE UTILITY SCISSOR RYL ST CS25 7",Model Number 96-1226; 15) ECONO STERILE UTILITY SCISS LM GR ST CS25 7",Model Number 96-1228; 16) ECONO STERILE MAYO DISS SCISS STR 9" STER25,Model Number 96-2260; 17) ECONO STERILE MAYO DISS SCISS CV 9"STRLCS/25,Model Number 96-2261; 18) ECONO STERILE MAYO DISS SCISS CVD 9" STER25,Model Number 96-2261A; 19) ECONO STERILE METZENBAUM SCIS STR7"STRLCS/25,Model Number 96-2263A; 20) ECONO STERILE METZENBAUM SCIS STR9"STER CS25,Model Number 96-2266; 21) ECONO STERILE MAYO DISS SCISS CVD 5.5"CS/25,Model Number 96-2433; 22) ECONO STERILE MAYO DISS SCISS CVD 6.75"CS/25,Model Number 96-2435; 23) ECONO STERILE METZ-NELSON SCISS CVD 9" CS/25,Model Number 96-2437; 24) ECONO STERILE METZ-NELSON SCISS CVD 9" CS/25,Model Number 96-2437A; 25) ECONO STERILE IRIS SCISS CVD S/S 3.5" CS/25,Model Number 96-2471; 26) ECONO STERILE TOENAIL SCISS CVD 4.5" STER 25,Model Number 96-2492A; 27) ECONO STERILE IRIS SCIS CVD DEL 4 STER CS/25,Model Number 96-2494A; 28) ECONO STERILE IRIS SCIS STR LG RG 4.5 STER25,Model Number 96-2495A; 29) ECONO STERILE IRIS SCISS STR S/S 3.5" CS/25,Model Number 96-2496; 30) ECONO STERILE IRIS SCIS STR S/S 3.5 STER C50,Model Number 96-2497; 31) ECONO STERILE IRIS SCIS CVD S/S 3.5 STER C50,Model Number 96-2499; 32) ECONO STERILE LISTER BAND SCISS 7 1/4" CS/25,Model Number 96-2500; 33) ECONO STERILE LISTER BAND SCISS 7 1/4" CS/25,Model Number 96-2500A; 34) ECONO STERILE LISTER BAND SCISS 5.5 STER C50,Model Number 96-2502; 35) ECONO STERILE LISTER BAND SCIS STER 5 1/2 50,Model Number 96-2502M; 36) ECONO STERILE LISTER BAND SCIS STER 5 1/2 25,Model Number 96-2503; 37) ECONO STERILE LISTER BAND SCIS STER 5 1/2 25,Model Number 96-2503A; 38) ECONO STERILE IRIS SCIS STR S/S 4.5 STER C50,Model Number 96-2504; 39) ECONO STERILE IRIS SCISS STR 4.5" STER CS/25,Model Number 96-2505; 40) ECONO STERILE IRIS SCISS STR 4.5" STER CS/25,Model Number 96-2505A; 41) ECONO STERILE IRIS SCIS CVD S/S 4.5 STER C50,Model Number 96-2506; 42) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/50,Model Number 96-2506M; 43) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/25,Model Number 96-2507; 44) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/25,Model Number 96-2507A; 45) ECONO STERILE SPENCER ST SCIS DEL 3.5 STER25,Model Number 96-2511A; 46) ECONO STERILE LITT SUT SCIS 5 1/2 STER CS/50,Model Number 96-2512; 47) ECONO STERILE LITT SUT SCISS 5 1/2 STER CS25,Model Number 96-2513; 48) ECONO STERILE OR SCIS STR B/B 5.5" STER CS50,Model Number 96-2514; 49) ECONO STERILE METZ SCISS STR STER 5.5" CS/50,Model Number 96-2516; 50) ECONO STERILE METZ SCISS STR STER 5.5" 25/CS,Model Number 96-2517; 51) ECONO STERILE METZ SCISS STRS 5.5" STER CS25,Model Number 96-2517A; 52) ECONO STERILE WIRE CUT SCIS ANG 4 3/4 STRL25,Model Number 96-2519; 53) ECONO STERILE OR SCISS STR S/B 5.5" STER C50,Model Number 96-2520; 54) ECONO STERILE OR SCIS STR S/B 5.5 STER CS50,Model Number 96-2520A;

Lot/Code Info: 1) 941-0918, UDI/DI 50649111344174, Lot codes MSS8; 2) 941-1556, UDI/DI 50649111447752, Lot codes FSS19, FSS23; 3) 941-1613, UDI/DI 50649111447912, Lot codes FSS17; 4) 94-1346, UDI/DI 50649111256613, Lot codes FSS8; 5) 94-1925, UDI/DI 50649111345966, Lot codes FSS10, FSS17, FSS20; 6) 94-4091, UDI/DI 50649111288454, Lot codes FSK12; 7) 94-5692, UDI/DI 50649111150126, Lot codes FSS20; 8) 94-6096, UDI/DI 50649111207509, Lot codes FSS5, FSS10, FSS17; 9) 94-6097, UDI/DI 50649111207622, Lot codes FSS26; 10) 96-1220, UDI/DI 50649111246096, Lot codes 724961220; 11) 96-1221, UDI/DI 50649111246140, Lot codes 824961221; 12) 96-1222, UDI/DI 50649111246287, Lot codes 724961222; 13) 96-1224, UDI/DI 50649111246546, Lot codes 724961224; 14) 96-1226, UDI/DI 50649111246867, Lot codes 724961226; 15) 96-1228, UDI/DI 50649111247178, Lot codes 824961228; 16) 96-2260, UDI/DI 50649111492622, Lot codes FSS17, FSS21; 17) 96-2261, UDI/DI 50649111439870, Lot codes FSS5; 18) 96-2261A, UDI/DI 50649111492646, Lot codes HSS23; 19) 96-2263A, UDI/DI 50649111487536, Lot codes SK-112; 20) 96-2266, UDI/DI 50649111488359, Lot codes FSS23; 21) 96-2433, UDI/DI 50649111440357, Lot codes FSS5; 22) 96-2435, UDI/DI 50649111440371, Lot codes FSS8; 23) 96-2437, UDI/DI 50649111440395, Lot codes FSS17, FSF21, FSS24; 24) 96-2437A, UDI/DI 50649111487543, Lot codes HSI; 25) 96-2471, UDI/DI 50649111440524, Lot codes 724962471; 26) 96-2492A, UDI/DI 50649111493933, Lot codes 0824962492A; 27) 96-2494A, UDI/DI 50649111488229, Lot codes HSI; 28) 96-2495A, UDI/DI 50649111488236, Lot codes HSI; 29) 96-2496, UDI/DI 50649111440630, Lot codes SK-127; 30) 96-2497, UDI/DI 50649111046924, Lot codes SK-127; 31) 96-2499, UDI/DI 50649111047341, Lot codes 824962499; 32) 96-2500, UDI/DI 50649111047617, Lot codes FSS7, FSS10, FSS26; 33) 96-2500A, UDI/DI 50649111487581, Lot codes HSI; 34) 96-2502, UDI/DI 50649111048041, Lot codes FSS7, FSS9, FSS10, FSS11, FSS15, FSS16, FSS19, FSS20; 35) 96-2502M, UDI/DI 50649111169289, Lot codes SK-133; 36) 96-2503, UDI/DI 50649111048225, Lot codes FSS5, FSS11, FSS15, FSS22; 37) 96-2503A, UDI/DI 50649111487574, Lot codes HSI; 38) 96-2504, UDI/DI 50649111048386, Lot codes FSS7, FSS8, FSS16, FSS17, FSS23, FSS26; 39) 96-2505, UDI/DI 50649111048577, Lot codes FSS5, FSS6; 40) 96-2505A, UDI/DI 50649111487628, Lot codes HSI; 41) 96-2506, UDI/DI 50649111048799, Lot codes SK-127; 42) 96-2506M, UDI/DI 50649111174535, Lot codes MSS8; 43) 96-2507, UDI/DI 50649111049017, Lot codes SK-124, SK-127; 44) 96-2507A, UDI/DI 50649111488243, Lot codes HSI; 45) 96-2511A, UDI/DI 50649111480704, Lot codes 60577; 46) 96-2512, UDI/DI 50649111049819, Lot codes FSS13, FSS15, FSS17, FSS19, FSS24; 47) 96-2513, UDI/DI 50649111050006, Lot codes FSS15; 48) 96-2514, UDI/DI 50649111050129, Lot codes FSS8; 49) 96-2516, UDI/DI 50649111050402, Lot codes SK-130; 50) 96-2517, UDI/DI 50649111050594, Lot codes SK-130; 51) 96-2517A, UDI/DI 50649111487680, Lot codes SK-112; 52) 96-2519, UDI/DI 50649111050976, Lot codes SK-126; 53) 96-2520, UDI/DI 50649111051119, Lot codes FSS7, FSS8, FSS10, FSS11, FSS16, FSS23; 54) 96-2520A, UDI/DI 50649111194090, Lot codes FSS8, FSS20, HSS8, HSS9, HSS17, HSS19; 55) 96-2521, UDI/DI 50649111051256, Lot codes FSS5, FSS8, FSS10, FSS19, FSS20, FSS22, FSS23, FSS24; 56) 96-2521A, UDI/DI 50649111487659, Lot codes SK-112; 57) 96-2522, UDI/DI 50649111051416, Lot codes FSS8, FSS20, FSS23, FSS24, FSS26; 58) 96-2523, UDI/DI 50649111051584, Lot codes FSS7, FSS8, FSS10, FSS17, FSS19, FSS20, FSS22; 59) 96-2523A, UDI/DI 50649111487666, Lot codes SK-112; 60) 96-2523M, UDI/DI 50649111199880, Lot codes MSS10; 61) 96-2524, UDI/DI 50649111051638, Lot codes FSS26; 62) 96-2527, UDI/DI 50649111052215, Lot codes FSS26; 63) 96-2530, UDI/DI 50649111052802, Lot codes FSS6, FSS7, FSS10, FSS20, FSS22, FSS24; 64) 96-2531, UDI/DI 50649111053069, Lot codes FSS5; 65) 96-2531A, UDI/DI 50649111487673, Lot codes SK-112; 66) 96-2592, UDI/DI 50649111064911, Lot codes FSS13; 67) 96-2593, UDI/DI 50649111065031, Lot codes FSS13; 68) 96-2596, UDI/DI 50649111065826, Lot codes FSF26; 69) 96-2596M, UDI/DI 50649111311275, Lot codes SK-133; 70) 96-2597, UDI/DI 50649111065888, Lot codes FSS10, FSS21, FSS24; 71) 96-2598, UDI/DI 50649111066205, Lot codes FSS10, FSS24, FSS25; 72) 96-2640, UDI/DI 50649111074347, Lot codes FSS20; 73) 96-2649, UDI/DI 50649111075849, Lot codes FSS10, FSS12, FSS13, FSS15, FSS16, FSS18, FSS20, FSS21; 74) 96-2649G, UDI/DI 50649111005082, Lot codes FSS8, FSS10, FSS12, FSS13, FSS15, FSS16, FSS17, FSS20; 75) 96-2650, UDI/DI 50649111076198, Lot codes FSS8, FSS16, FSS17, FSS22, FSS23, FSS24, FSS26; 76) 96-2651, UDI/DI 50649111076266, Lot codes SK-127, SK-129; 77) 96-2654, UDI/DI 50649111076884, Lot codes FSS9, FSS10, FSS16, FSS19; 78) 96-2662, UDI/DI 50649111078246, Lot codes FSS13, FSS15; 79) 96-2673A, UDI/DI 50649111493056, Lot codes SK-134; 80) 96-2680, UDI/DI 50649111081109, Lot codes FSS20, FSS22, FSS26; 81) 96-2682, UDI/DI 50649111081499, Lot codes FSS10, FSS13, FSS21, FSS22, FSS26; 82) 96-2682A, UDI/DI 50649111487703, Lot codes SK-112; 83) 96-2683A, UDI/DI 50649111487710, Lot codes HSI; 84) 96-2690A, UDI/DI 50649111487727, Lot codes HSI; 85) 96-2691A, UDI/DI 50649111487734, Lot codes HSI; 86) 96-2703, UDI/DI 50649111084537, Lot codes 724962703; 87) 96-2704, UDI/DI 50649111084735, Lot codes 724962704; 88) 96-2720A, UDI/DI 50649111487697, Lot codes SK-112; 89) 96-2728, UDI/DI 50649111088221, Lot codes FSS10, FSS13, FSS24.

Quantity Affected: 252865 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