Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1719-2019Class II

Sterile Nail Clipper Concave Edge (67710)

Centurion Medical Products, LP / initiated 2019-03-29 / Terminated / root cause: packaging

Centurion Medical Products Corporation began a recall of Sterile Nail Clipper Concave Edge (67710) on . FDA classified it as Class II and gives the reason as "Compromised seal on the sterile barrier pouch". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1719-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Centurion Medical Products, LP
Product
Sterile Nail Clipper Concave Edge (67710)
Product code
PWC General Wellness Product
Reason for recall
Compromised seal on the sterile barrier pouch.
Root cause tag
packaging
FDA root cause
Packaging
Action
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 [email protected]
Distribution
US nationwide distribution.
Product codes and lots
Lot 2018120701, exp 2023-11-30

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1719-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1719-2019Class IITerminatedVoluntary: Firm initiated
Z-1720-2019Class IITerminatedVoluntary: Firm initiated