Medline Nasal Pack Procedure Kits Recalled for Potential Endotoxin Contamination
Medline custom nasal pack procedure kits contain non-sterile surgical components with potential endotoxin contamination. Customers should discontinue use and contact Medline.
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 of surgical procedure kits containing non-sterile components with potential for endotoxin contamination. Although no illnesses or hospitalizations are reported in the source, non-sterile surgical materials represent a risk-of-harm product, meeting the High severity criterion.
Plain-English summary
Medline Industries is recalling custom medical procedure kits labeled as NASAL PACK, REF DYNJ67789A. The kits contain non-sterile Codman Surgical Patties and Surgical Strips, which have the potential for endotoxin contamination.
The recalled kits were distributed nationwide in the US and internationally in the UAE and Canada. A total of 80 units are included in this recall. Affected kits are identified by lot numbers 21GBW066, 21JBK474, 21KBS434, and 21KBX401.
Customers should immediately stop using these kits. Contact Medline Industries for instructions on returns or replacement of affected inventory.
The recalled product
- Product
- Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- endotoxin
- non-sterile
- contamination
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 (6)
- 1) REF DYNJ67789A
- UDI/DI 10193489945645 (EA) 40193489945646 (CS)
- Lot Numbers: 21GBW066
- 21JBK474
- 21KBS434
- 21KBX401
Distribution
Distributed nationwide across the United States.
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