Device product
Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
Z-2102-2017
Product summary
- Event
- Event 77063
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 38 cases (3-48pk/35-20pk)
- Official record key
device-enforcement:Z-2102-2017
Official wording
Reason: Lint present on sterile Operating Room Towels.
Code information: Material Number: AVID260, Lot #231253, Exp. Date: 10/31/2021 (48 pk) and Material Number: MSPT504, Lot #229259, Exp. Date: 10/12/2021 (20 pk).
Distribution pattern: AR, IN and NV.
Derived failure modes
-
Unknown
Lint present on sterile Operating Room Towels.