Centurion OB Tray medical kit recalled due to potential non-sterility
Medline's Centurion OB TRAY convenience kits with breather pouch lot 323080002 may be non-sterile if the pouch seal is opened or becomes unsealed, posing a risk in obstetric procedures.
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 recall. The hazard is potential non-sterility if seals are compromised, which poses a significant risk of harm in obstetric procedures. No illnesses or injuries have been reported, which limits the score to High per the rubric rule for theoretical hazards without reported illness.
Plain-English summary
Medline Industries is recalling Centurion OB TRAY (REF MNS13965A) medical procedure convenience kits that were packaged in specific breather pouches. The recall affects kits from breather pouch lot 323080002.
If the vendor seal on the breather pouch is opened or becomes unsealed, the kit contents may no longer maintain sterility. This creates the potential for non-sterile medical products to be used in procedures.
The affected kits were distributed worldwide, including throughout the United States, Canada, and Panama.
Healthcare facilities that received kits from this lot should inspect the breather pouch seals for any signs of opening or damage before use. Kits with unsealed or compromised seals should not be used. Any adverse events should be reported to Medline Industries or the FDA.
The recalled product
- Product
- Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
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)
- UDI/DI 40653160995877 (each)
- 10653160995876 (case)
- Lot Numbers: 24ABD184
Distribution
Distributed nationwide across the United States.
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