Medline sterile surgical convenience kits with potentially weak seals
Medline Industries is recalling 33 models of sterile surgical convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise sterility of the kits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of sterile medical device convenience kits where compromised packaging seals could result in non-sterile surgical instruments being used in medical procedures. Although no illnesses or injuries have been reported, the risk-of-harm from use of non-sterile surgical equipment in invasive procedures is significant and meets the High threshold.
Plain-English summary
Medline Industries, LP is recalling 33 models of sterile surgical convenience kits distributed worldwide, including throughout the US, Canada, Mexico, Panama, and the Virgin Islands. These kits are used for various surgical procedures including oculoplastic, plastic surgery, breast procedures, and ENT procedures.
The recall is due to a potential for open or weak seals on the breather pouches used to package the sterile convenience kits. Compromised seals could allow the sterilized contents to become non-sterile before use in surgical procedures.
The affected models include DYNJ43914B, DYNJ65109, DYNJ34160D, DYNJ84991, DYNJ66056, DYNJ66212A, DYNJ37231B, DYNJ52658D, DYNJ37316D, DYNJ57440D, DYNJ63696, DYNJ68328, DYNJ63753, DYNJ64886A, DYNJ46737A, DYNJ40620F, DYNJ64712B, DYNJ34199A, DYNJ55985D, DYNJ67772A, DYNJ35741D, DYNJ38907, DYNJ67882, and DYNJ37142D, with specific lot numbers identified. A total of 4,094 units were distributed.
Healthcare facilities and surgical centers using these kits should immediately cease use of affected lots and inspect for open or weak seals. Facilities should contact Medline Industries for instructions on replacement or return of the recalled products.
The recalled product
- Product
- 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, Mo
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- seal-integrity
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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