Medline Sterile Surgical Kits: Weak Packaging Seals on Breather Pouches
Medline is recalling 706 units of sterile surgical convenience kits due to potential open or weak seals on packaging breather pouches that could compromise product sterility.
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 without reported illnesses or injuries. The hazard is theoretical—potential for weak or open seals that could compromise product sterility. Under the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Medline Industries is recalling 706 units of sterile surgical convenience kits used for various gynecological and surgical procedures.
The recall is due to a potential for open or weak seals on breather pouches used to package the sterile kits. Compromised seals could affect the sterility of the products.
The affected kits have been distributed worldwide, including the United States, Canada, Mexico, Panama, and the Virgin Islands. Affected model numbers include DYNJ69733, DYNJ39904A, DYNJ64651A, DYNJ49250F, DYNJ47552C, DYNJ67945, DYNJ25892K, DYNJ41670B, DYNJ67227, DYNJ41790F, DYNJ49251C, DYNJ24338I, CDS982727L, and DYNJ908712B.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS. GYNE
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- weak-seal
- contamination-risk
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) DYNJ69733
- UDI-DI: 10193489974089(each)
- 40193489974080(case)
- Lot Number: 24IBE079
- 2) DYNJ39904A
- UDI-DI: 10888277801905(each)
- 40888277801906(case)
- Lot Number: 24IBF466
- 3) DYNJ64651A
- UDI-DI: 10195327057381(each)
- 40195327057382(case)
- Lot Number: 24IBS312
- 4) DYNJ49250F
- UDI-DI: 10195327680145(each)
- 40195327680146(case)
- Lot Number: 24JBM609
- 5) DYNJ47552C
- UDI-DI: 10193489845594(each)
- 40193489845595(case)
- Lot Number: 24JBN271
Distribution
Distributed nationwide across the United States.
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