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Customed, Inc Recall: GENERAL MINOR PK 5/CS Used by medical staff to perform surgical proc

Customed, Inc Recall: GENERAL MINOR PK 5/CS Used by medical staff to perform surgical proc is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Customed, Inc; Product: GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healin

Recalling firmCustomed, Inc
ProductGENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Reason for recallRecall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionDistributed Only in Puerto Rico.
Recall initiated20150710
Recall numberZ-2704-2015
Categorydevice
StatePR
CountryUnited States

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