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Customed, Inc recalls Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff
Recalled April 20, 2016 · FDA recall Z-1475-2016 · Customed
Hazard
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. · FDA Class II
Units
1148
Sold at
Distributed only in Puerto Rico.
Description
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product
Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Manufacturer(s)
Customed, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →