| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2351-2014 |
| Recall Event ID |
68536 |
| Product Classification |
General surgery tray (kit) - Product Code LRO
|
| Product |
GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF
(2) BOWL UTILITY 16oz LIF
(1) TIP CAUTERY POLISHER LIF
(3) TOWELS ABSORBENT 15" X 20" LIF
(1) BOWL UTILITY 32oz
(1) BAG SUTURE FLORAL
(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF
(10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF
(2) GOWN IMPERVIOUS REINFORCED LARGE SMS LIF
(1) CAUTERY PENCIL ROCKER SWITCH LIF
(1) BLADE SURGICAL #10 STAINLESS STEEL
(1) TUBE SUCTION CO NNECTING ~" X 12' LIF
(5) LAP SPONGE PREWASH 18" X 18" XRD LIF
(2) LITE GLOVES LIF
(1) DRAPE LAPAROTOMY WITH POUCH 102" X 121" X 78" STD SMS
(4) DRAPE UTILITY WITH TAPE LIF
(1) CONTAINER SPECIMEN 4oz WITH LID & LABEL
(1) BLADE SURGICAL #15 CARBON STEEL
(2) SHEET DRAPE 41" X 69" MEDIUM LIF
(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-787, 25 lots: 109010128 112030747 112052015 112062577 112093733 112114397 112114483 112125114 113015516 113025969 113036383 113047206 113057819 113068181 113078606 113099296 113099577 131110278 131110606 131210973 140111454 140211879 140312331 140412842 140513251 |
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 |
25 lots; 4275 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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