Surgical convenience kits recalled for sterile barrier defect
Medline Industries recalls 1537 Lab Draw Kits (Reorder #DYNDH1641A, Lot 22HMH339) distributed nationwide due to a perforated outer bag that cannot maintain sterility, compromising the protective barrier.
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: FDA Class II recall involving a structural packaging defect that compromises the sterile barrier of a medical device kit. No illnesses or injuries have been reported, making this a risk-of-harm situation where the theoretical hazard of contamination has not yet resulted in documented harm.
Plain-English summary
Medline Industries, LP is recalling 1537 Surgical Convenience Kits labeled MEDLINE LCPH LAB DRAW KIT (Reorder Number DYNDH1641A, Lot 22HMH339) distributed nationwide. These kits are designed to provide sterile contents for medical procedures and lab work.
The outer bag has a perforation that prevents the exterior wrapping from being sterile. While the contents inside the kit wrapping remain sterile, the non-sterile outer surface creates a potential contamination pathway.
This defect compromises the integrity of the sterile barrier that the kit is designed to provide during handling, storage, and use. Healthcare providers should be aware that the external surface cannot be relied upon as a sterile barrier.
The recalled product
- Product
- Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Hazard
- sterility-compromise
- 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 (3)
- Reorder Number DYNDH1641A
- GTIN 40195327005830
- Lot # 22HMH339
Distribution
Distributed nationwide across the United States.
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