| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2384-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Ring, laparotomy - Product Code FHI
|
| Product |
PREMIUM LAPAROTOMY PACK - CUSTOMED-
(1) DRAPE T LAPAROT 102" X 78" X 121"
(1) GOWN XL SMS IMPERVIOUS REINFORCED
(1) COVER TABLE REINFORCED 50" X 90" LIF
(1) COVER MAYO STAND REINFORCED LIF
(4) DRAPE UTILITY WITH TAPE LIF
(4) TOWELS ABSORBENT 15" X 20" LIF
(5) SPONGE LAP PRE-WASH 18" X 18" XRD LIF
(1) YANKAUER SUCTION TUBE W/0 VENT LIF
(1) TUBE SUCTION CONNECT~~~ X 12' LIF
(1) BLADE SURGICAL #10 CARBON STEEL
(1) BLADE SURGICAL #15 CARBON STEEL
(1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF
(2) DRAPE SHEET 42" X 55" LIF
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
(1) GOWN SURG REINFORCED LARGE TOWEL/WRAP
|
| Code Information |
Product code 900-1296, 51 lots: 110102576 110112604 110112865 110122889 110123065 111010033 111020358 111030562 111030827 111030934 111041085 111051267 111051325 111061488 111061600 111061645 111072036 111082183 111082197 111092481 111102671 111112927 111123333 112010033 112010243 112020326 112030613 112041246 112041437 112062581 112114631 112124934 112125280 113015634 113025909 113036727 113047212 113047323 113068143 113078567 113078691 113089183 113109718 131110066 131110595 131210958 140111405 140211870 140412595 140412882 140513344 |
Recalling Firm/
Manufacturer |
Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
|
| For Additional Information Contact |
Rosemari Melendez
787-622-5151 Ext. 7540
|
Manufacturer Reason
for Recall |
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
|
FDA Determined
Cause 2 |
Package design/selection |
| Action |
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540 |
| Quantity in Commerce |
51 lots; 11070 units (multiple units per lot) |
| Distribution |
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico. |
| 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.
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