Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC

Summary

The FDA issued a Class II for Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK by MEDLINE INDUSTRIES, LP - Northfield. Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits..

Details

Product Description

Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK, Model Number: DYNJ66056; 6) MUSCLE PLASTIC PACK, Model Number: DYNJ66212A; 7) MINOR PLASTIC PACK, Model Number: DYNJ37231B; 8) GENERAL BREAST GRH-LF, Model Number: DYNJ52658D; 9) GENERAL BREAST GRH-LF, Model Number: DYNJ52658D; 10) FACE PACK, Model Number: DYNJ37316D; 11) PLASTIC PACK-LF, Model Number: DYNJ57440D; 12) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 13) MINOR PLASTIC PACK, Model Number: DYNJ37231B; 14) SATELLITE MINOR PLASTIC PACK, Model Number: DYNJ63696; 15) FACIAL/EYE PACK, Model Number: DYNJ68328; 16) BREAST PACK, Model Number: DYNJ63753; 17) BREAST PACK, Model Number: DYNJ63753; 18) TUMMY PACK, Model Number: DYNJ64886A; 19) PLASTIC TORSO PK TEGH-LF, Model Number: DYNJ46737A; 20) PLASTIC BREAST PACK, Model Number: DYNJ40620F; 21) PLASTIC ENT PACK, Model Number: DYNJ64712B; 22) PLASTIC SURGERY SERV-DR GARAZO, Model Number: DYNJ34199A; 23) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 24) OCULAR PLASTICS, Model Number: DYNJ55985D; 25) TUMMY PACK, Model Number: DYNJ64886A; 26) MUSCLE PLASTIC PACK, Model Number: DYNJ66212A; 27) ZURI BREAST PACK, Model Number: DYNJ67772A; 28) PLASTIC TORSO PK TEGH-LF, Model Number: DYNJ46737A; 29) TUMMY PACK, Model Number: DYNJ64886A; 30) OCCULAR PLASTIC PACK, Model Number: DYNJ35741D; 31) FACELIFT PACK, Model Number: DYNJ38907; 32) BREAST PACK, Model Number: DYNJ67882; 33) KDOP PLASTIC PACK, Model Number: DYNJ37142D

Lot/Code Info: 1) DYNJ43914B, UDI-DI: 10889942437078(each), 40889942437079(case), Lot Number: 24IBH633; 2) DYNJ65109, UDI-DI: 10193489243826(each), 40193489243827(case), Lot Number: 24IBH739; 3) DYNJ34160D, UDI-DI: 10889942213542(each), 40889942213543(case), Lot Number: 24IBH802; 4) DYNJ84991, UDI-DI: 10195327444075(each), 40195327444076(case), Lot Number: 24IBL195; 5) DYNJ66056, UDI-DI: 10193489318128(each), 40193489318129(case), Lot Number: 24IBR304; 6) DYNJ66212A, UDI-DI: 10195327345075(each), 40195327345076(case), Lot Number: 24JBL025; 7) DYNJ37231B, UDI-DI: 10884389871652(each), 40884389871653(case), Lot Number: 24JBM075; 8) DYNJ52658D, UDI-DI: 10195327468828(each), 40195327468829(case), Lot Number: 24JBM318; 9) DYNJ52658D, UDI-DI: 10195327468828(each), 40195327468829(case), Lot Number: 24JBM914; 10) DYNJ37316D, UDI-DI: 10193489672763(each), 40193489672764(case), Lot Number: 24JBT528; 11) DYNJ57440D, UDI-DI: 10193489238655(each), 40193489238656(case), Lot Number: 24JBT877; 12) DYNJ84991, UDI-DI: 10195327444075(each), 40195327444076(case), Lot Number: 24JBV138; 13) DYNJ37231B, UDI-DI: 10884389871652(each), 40884389871653(case), Lot Number: 24JBV645; 14) DYNJ63696, UDI-DI: 10193489754704(each), 40193489754705(case), Lot Number: 24JBV846; 15) DYNJ68328, UDI-DI: 10193489823554(each), 40193489823555(case), Lot Number: 24JBW152; 16) DYNJ63753, UDI-DI: 10193489757330(each), 40193489757331(case), Lot Number: 24JBW480; 17) DYNJ63753, UDI-DI: 10193489757330(each), 40193489757331(case), Lot Number: 24JBX780; 18) DYNJ64886A, UDI-DI: 10193489916355(each), 40193489916356(case), Lot Number: 24JBX789; 19) DYNJ46737A, UDI-DI: 10889942116553(each), 40889942116554(case), Lot Number: 24KBA440; 20) DYNJ40620F, UDI-DI: 10195327631321(each), 40195327631322(case), Lot Number: 24KBB123; 21) DYNJ64712B, UDI-DI: 10198459166037(each), 40198459166038(case), Lot Number: 24KBB906; 22) DYNJ34199A, UDI-DI: 10884389380406(each), 40884389380407(case), Lot Number: 24KBC573; 23) DYNJ43914B, UDI-DI: 10889942437078(each), 40889942437079(case), Lot Number: 24KBC625; 24) DYNJ55985D, UDI-DI: 10193489288940(each), 40193489288941(case), Lot Number: 24KBC670; 25) DYNJ64886A, UDI-DI: 10193489916355(each), 40193489916356(case), Lot Number: 24KBC738; 26) DYNJ66212A, UDI-DI: 10195327345075(each), 40195327345076(case), Lot Number: 24KBC750; 27) DYNJ67772A, UDI-DI: 10195327209704(each), 40195327209705(case), Lot Number: 24KBC752; 28) DYNJ46737A, UDI-DI: 10889942116553(each), 40889942116554(case), Lot Number: 24KBE585; 29) DYNJ64886A, UDI-DI: 10193489916355(each), 40193489916356(case), Lot Number: 24KBF385; 30) DYNJ35741D, UDI-DI: 10889942108534(each), 40889942108535(case), Lot Number: 24KBF775; 31) DYNJ38907, UDI-DI: 10884389722176(each), 40884389722177(case), Lot Number: 24KBH241; 32) DYNJ67882, UDI-DI: 10193489449532(each), 40193489449533(case), Lot Number: 24KBH367; 33) DYNJ37142D, UDI-DI: 10195327467708(each), 40195327467709(case), Lot Number: 24KBI482

Quantity Affected: 4094 units

Reason for Recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-03-03

Company