| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2335-2014 |
| Recall Event ID |
68536 |
| Product Classification |
laparoscopy kit - Product Code FDE
|
| Product |
LAPAROSCOPY GYN PACK - -
(1) BLADE SURGICAL #11 STAINLESS STEEL
(4) DRAPE UTILITY WITH TAPE LIF
(2) ABSORBENT TOWEL 15" X 20" LIF
(1) GOWN IMPERVIOUS REINFORCED LARGE SMS
(1) TOWEL CLOTH HUCK BLUE
(1) BLADE SURGICAL #15 CARBON STEEL
(2) UTILITY BOWL 16oz
(1) UTILITY BOWL 32oz
(2) LEGGINS WITH 7" CUFF 30" X 42" LIF
(1) EMESIS BASIN 10in 700cc
(1) DRAPE VIDEO CAMERA 13cm X 244cm LIF
(1) MAYO STAND COVER REINFORCED LIF
(10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF
(2) TUBE SUCTION CONNECT 114" X 12' LIF
(1) TABLE COVER REINFORCED 44" X 78" UF
(1) DRAPE LAP. PERINEAL 102" X 97" WITH POUCH
(1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-605, 34 lots: 110092266 110102447 110112666 110123109 111010142 111020291 111030694 111040908 111061557 111071939 111082104 111092395 111102768 111113129 111123270 112010189 112020490 112030886 112051997 112062497 112072807 112083435 112093728 112124593 112125104 113078336 113088877 113099445 113109859 131110267 131210832 140111091 140312177 140412696 |
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 |
34 lots; 1136 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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