| Date Initiated by Firm | January 07, 2016 |
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| Date Posted | April 14, 2016 |
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| Recall Status1 |
Terminated 3 on May 03, 2017 |
| Recall Number | Z-1419-2016 |
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| Recall Event ID |
72992 |
| 510(K)Number | K902032 |
|---|
| Product Classification |
Obstetrical kit - Product Code OKV
|
| Product | Catalog Number: 9001297
PREMIUM OBSTETRICAL SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. |
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| Code Information |
LOTS: SL15169 (150619380) 30-JUN-16 SL15174 (150619380) 30-JUN-16 SL15201-01 (150719634) 31-JUL-16 SL15212 (150720070) 31-JUL-16 SL15212 (150720071) 31-JUL-16 SL15272 (150920769) 30-SEP-16 SL15273 (150920769) 30-SEP-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. |
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FDA Determined
Cause 2 | Packaging |
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| Action | Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016. |
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| Quantity in Commerce | 220 |
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| Distribution | Distributed only in Puerto Rico. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
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) Database | 510(K)s with Product Code = OKV
|
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