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Customed, Inc Recall: Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER

Customed, Inc Recall: Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Customed, Inc; Product: Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical proc

Recalling firmCustomed, Inc
ProductCatalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT 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 initiated20160107
Recall numberZ-1411-2016
Categorydevice
StatePR
CountryUnited States

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