Date Initiated by Firm | May 20, 2014 |
Date Posted | August 29, 2014 |
Recall Status1 |
Terminated 3 on August 14, 2017 |
Recall Number | Z-2355-2014 |
Recall Event ID |
68536 |
Product Classification |
General surgery tray (kit) - Product Code LRO
|
Product | UROLOGY PACK-
(2) SYRINGE 30ML SLIP TIP 1 ML LIF
(2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP
(1 0) GAUZE SPONGE 4" X 4" 12 PLY
(1) URINARY DRAINAGE BAG 2000ML ANTI-REFLUX LIF
(1) TABLE COVER REINFORCED 44" X 78" LIF
(1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS
(3) TOWELS ABSORBENT 15" X 20" LIF
(1) TUR Y SET 81"2.1m REGULAR CLAM ST.
(1) TUBE SUCTION CONNECT Y4" X 12' LIF
(1) BAG SUTURE FLORAL
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
Code Information |
Product code 900-868, 36 lots: 111030667 111040921 111051390 111061692 111071970 111082114 111092560 111102783 111123143 111123300 112010206 112020509 112030750 112041359 112052020 112083060 112093955 112114402 112114485 112114583 112125119 113015518 113015570 113036769 113057511 113078350 113088896 113099297 113109649 113109878 131210844 140111254 140211858 140412476 140412909 140513484 |
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 | 36 lots; 1900 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.
|