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U.S. Department of Health and Human Services

Class 2 Device Recall Customed

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 Class 2 Device Recall Customedsee related information
Date Initiated by FirmJanuary 07, 2016
Date PostedApril 14, 2016
Recall Status1 Terminated 3 on May 03, 2017
Recall NumberZ-1412-2016
Recall Event ID 72992
510(K)NumberK962652 
Product Classification Kit, catheter, foley (excludes hiv testing) - Product Code NWR
ProductCatalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Code Information LOTS: SL15183 (150619119) 30-JUN-16 SL15184 (150619119) 30-JUN-16 SL15187 (150619119) 30-JUN-16 SL15212 (150719823) 31-JUL-16 SL15215 (150719823) 31-JUL-16 SL15216 (150719823) 31-JUL-16 SL15217 (150720152) 31-JUL-16 SL15217 (150719823) 31-JUL-16 SL15219 (150719823) 31-JUL-16 SL15219 (150720152) 31-JUL-16 SL15223 (150720152) 31-JUL-16 SL15224 (150720152) 31-JUL-16 SL15225 (150719823) 31-JUL-16 SL15252 (150820683 31-AUG-16 SL15254 (150820683) 31-AUG-16 SL15257 (150820683) 31-AUG-16 
Recalling Firm/
Manufacturer		 Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
Manufacturer Reason
for Recall		Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
FDA Determined
Cause 2		Packaging
ActionRecall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
Quantity in Commerce2920
DistributionDistributed only in Puerto Rico.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NWR
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