FDA Device Recalls

Recalls /

#172293

Product

Sterile Nail Clipper Concave Edge (67710)

FDA product code
PWCGeneral Wellness Product
Device class
Class N
Medical specialty
Unknown
Affected lot / code info
Lot 2018120701, exp 2023-11-30

Why it was recalled

Compromised seal on the sterile barrier pouch.

Root cause (FDA determination)

Packaging

Action the firm took

On March 29, 2019, Centurion issued URGENT PRODUCT RECALL NOTICES to customers via courier service. Customers were advised to take the following actions: 1) Inspect stock and quarantine product 2) Discontinue use of product immediately 3) Complete and return the accountability record via fax to 517-546-3356 or via email to Lcarpenter@centurionmp.com

Recalling firm

Firm
Centurion Medical Products Corporation
Address
100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern
US nationwide distribution.

Timeline

Recall initiated
2019-03-29
Terminated
2020-05-08
Status

Source: openFDA Device Recall endpoint. Recall record ID #172293. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

— recall: Sterile Nail Clipper Concave Edge (67710) · FDA Device Recalls