| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2409-2014 |
| Recall Event ID |
68536 |
| Product Classification |
General surgery tray (kit) - Product Code LRO
|
| Product |
MINOR LAPAROTOMY PACK -
(1) TABLE COVER 50" X 90" REINFORCED LIF
(1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP
(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF
(3) TOWELS ABSORBENT 15" X 20" LIF
(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF
(2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR LIF
(5) LAP SPONGE PREWASH XRD L/F
(4) DRAPE UTILITY WITH TAPE LIF
(2) LITES GLOVE LIF
(1) TUBE SUCTION CONNECT. ~" X 12' LIF
(1) COVER MAYO STAND REINFORCED LIF
(1) UTILITY BOWL 32oz
(2) UTILITY BOWL 16oz
(1) SPECIMEN CONTAINER 4oz WITH LID & LABEL
(1) CAUTERY TIP POLISHER LIF
(1) BLADE SURGICAL #10 CARBON STEEL
(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF
(1) BAG SUTURE FLORAL
(1) DRAPE SHEET MEDIUM 41" X 69" LIF
(1) DRAPE LAP WITH POUCH SMS STD L/F
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-1735, 50 lots: 110102434 110112619 110112893 111010068 111020366 111030604 111040842 111051280 111061589 111071909 111082065 111082258 111092365 111102646 111102700 111112936 111112963 111123380 112010087 112010246 112020405 112030642 112041200 112051874 112062448 112072785 112083406 112114610 112125032 112125313 113015434 113025948 113026232 113036783 113057399 113057692 113057813 113068157 113078569 113089200 113099567 131110069 131110403 131110580 131210964 140111412 140211885 140312330 140412886 140513347 |
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 |
50 lots; 9749 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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