Medline Sterile Procedure Kits recalled for potential seal issues
Medline Industries is recalling multiple sterile procedure kits due to potential open or weak seals on breather pouches used for packaging. The affected kits were distributed worldwide including the US and several other countries.
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 involving sterile medical device kits where packaging integrity is compromised, creating a potential risk of harm to patients and healthcare workers through loss of sterility. The source text explicitly addresses only the potential hazard without reporting any illnesses or injuries, placing this at the High level per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 1098 units of Medline Convenience kits used for various procedures, including ED CRASH C-SECTION TRAY, C-SECTION PCH-LF, C-SECTION PACK-LF, NHS - C-SECTION SCG, C-SECTION CDS, C-SECTION ADD ON PACK, EMERGENCY BIRTH PACK, C-SECTION PACK, and C-SECTION CLOSURE PACK models. The recall is due to a potential for open or weak seals on purchased breather pouches used for packaging these sterile convenience kits.
The affected products were distributed worldwide, including nationwide in the US and in Canada, Mexico, Panama, and the Virgin Islands. Twelve different model numbers and lot numbers are involved in this recall, each with specific UDI-DI codes provided by the manufacturer.
Customers who have received these kits should contact Medline Industries for instructions on how to proceed. Healthcare facilities and medical professionals should verify they do not have affected units by checking the model numbers and lot numbers listed in the recall notice.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,098
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) MNS13635A
- UDI-DI: 10653160994244(each)
- 40653160994245(case)
- Lot Number: 24IBH747
- 2) DYNJ81281
- UDI-DI: 10195327103620(each)
- 40195327103621(case)
- Lot Number: 24JBM309
- 3) OBK387M
- UDI-DI: 10889942686810(each)
- 40889942686811(case)
- Lot Number: 24JBM385
- 4) DYNJ81281
- Lot Number: 24JBM576
- 5) DYNJ40573A
- UDI-DI: 10888277988514(each)
- 40888277988515(case)
- Lot Number: 24JBM871
- 6) CDS983998C
- UDI-DI: 10193489776713(each)
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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