Medline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk
Medline is recalling 194 drape packs from breather pouch lot 323080002 that may be non-sterile if the seal is opened. The kits were distributed in the US, Canada, and Panama.
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 medical device with potential non-sterile product hazard if the breather pouch seal is opened. Meets rubric criterion for high-risk products: risk-of-harm without reported injury. No illnesses or adverse events mentioned in the source.
Plain-English summary
Medline Industries is recalling medical procedure convenience kits labeled as universal drape packs (REF DYNJ44114) and drape packs (REF DYNJ82663B). The recall affects 194 units distributed in the United States, Canada, and Panama. The affected kits were packaged in breather pouches from lot 323080002.
If the breather pouch seal is opened or unsealed, the sterile barrier may be compromised. There is potential for non-sterile product to be used during medical procedures under these conditions.
The affected product lot numbers are 24ABB398 and 23LBV498. Healthcare providers and users should not use these recalled products.
The recalled product
- Product
- Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile-product
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 (8)
- a) REF DYNJ44114
- UDI/DI 40888277202055 (each)
- 10888277202054 (case)
- Lot Numbers: 24ABB398
- b) REF DYNJ82663B
- UDI/DI 40195327544325 (each)
- 10195327544324 (case)
- Lot Numbers: 23LBV498
Distribution
Distributed nationwide across the United States.
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