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Recall Observatory FDA recall evidence

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

April 19, 2017

Class II

Product summary

Firm
Medical Action Industries Inc
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

    reason.no_named_rule · v1.0.0

    Lint present on sterile Operating Room Towels.