Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling multiple sterile convenience kits used for obstetric and gynecological procedures due to potential weak or open seals on breather pouches, which could compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 devices with a potential compromise to product sterility. Although no illnesses or injuries have been reported, weak or open seals on sterile procedure kits pose a meaningful risk of contamination that could result in patient harm.
Plain-English summary
Medline Industries, LP is recalling sterile convenience kits used for various procedures, including obstetric and gynecological applications. The kits are being recalled due to a potential for open or weak seals on purchased breather pouches used in packaging. These pouches are intended to maintain sterility during product storage and use.
The recalled kits include 24 different model numbers, with approximately 2,531 units affected. The products have been distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the Virgin Islands.
Customers who have received affected kits should stop using them and contact Medline Industries for guidance on replacement or disposal. Healthcare facilities should verify whether they have received products from the affected lot numbers listed in the recall notice.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 2,531
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) DYNJ68673
- UDI-DI: 10193489839951(each)
- 40193489839952(case)
- Lot Number: 24IBG873
- 2) DYNJ66290A
- UDI-DI: 10193489461428(each)
- 40193489461429(case)
- Lot Number: 24IBG957
- 3) DYNJ24159C
- UDI-DI: 10198459032394(each)
- 40198459032395(case)
- Lot Number: 24IBL229
- 4) DYNJ54484A
- UDI-DI: 10193489813074(each)
- 40193489813075(case)
- Lot Number: 24IBS805
- 5) DYNJS3040
- UDI-DI: 10884389602225(each)
- 40884389602226(case)
- Lot Number: 24JBL655
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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