| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2424-2014 |
| Recall Event ID |
68536 |
| Product Classification |
laparoscopy kit - Product Code FDE
|
| Product |
LAPAROSCOPY PACK -
( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F
( 1) NEEDLE ULTRA VERES 120MM LIF
( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF
( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF
(1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III
(1) MAYO STAND COVER REINFORCED LIF
(5) SPONGE LAP PREWASH 18" X 18" XRD LIF
( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF
( 1) BOWL UTILITY 16oz. LIF
(1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF
(1) DRAPE LASER CAMERA W/EL 6" X 96" LIF
(1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF
(4) DRAPE UTILITY WITH TAPE LIF
(4) TOWELS ABSORBENT 15" X 20" LIF
(1) DRAPE ENDOSCOPY 100" X 123%" X 77" WITH TROUGHS L/F
(2) SHEET DRAPE 42" X 57" SMS LIF
(1) BLADE SURGICAL #11 STAINLESS STEEL
( 1) TIME OUT BEACON NON WOVEN ST L/F
(6) GAUZE SPONGE 2" X 2" 4PL Y LIF
( 1) BLADE SURG. #15 CARBON STEEL
( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF
(1) TABLE COVER REINFORCED 50" X 90" L/F
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Product code 900-1967, 19 lots: 111123453 112030696 112041219 112041457 112051908 112062470 112083417 112125164 113015692 113025952 113026107 113026233 113047010 113057694 113078292 140211807 140312103 140412626 140412893 |
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 |
19 lots; 351 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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