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Recall Observatory FDA recall evidence

Device product

Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-1474-2016

January 07, 2016

Class II

Product summary

Firm
Customed, Inc
Event
Event 72992
Status
Terminated
Classification
Class II
Quantity
5712
Official record key
device-enforcement:Z-1474-2016

Official wording

Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Code information: LOTS: SV15168 (150418240) 30-APR-16 SL15209 (150719850) 31-JUL-16 SL15218 (150719850) 31-JUL-16 SL15229 (150719850) 31-JUL-16 SL15244 (150820336) 31-AUG-16 SL15251 (150719850) 31-JUL-16 SL15252 (150719850) 31-JUL-16 SL15254 (150719850) 31-JUL-16 SL15254 (150820336) 31-AUG-16 SL15257 (150820336) 31-AUG-16 SL15258 (150820336) 31-AUG-16

Distribution pattern: Distributed only in Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    inadequate validation/qualification of sterilization processes
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    inadequate validation/qualification of sterilization