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Customed, Inc Recall: Cesarean Pack, Catalog number 900-403. Used by medical staff to perf

Customed, Inc Recall: Cesarean Pack, Catalog number 900-403. Used by medical staff to perf is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Customed, Inc; Product: Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, sutu

Recalling firmCustomed, Inc
ProductCesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason for recallSignificant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
ClassificationClass I (most serious — reasonable probability of serious health consequences or death)
StatusTerminated
DistributionUS Distribution to Florida, New York and Puerto Rico..
Recall initiated20141008
Recall numberZ-0377-2015
Categorydevice
StatePR
CountryUnited States

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