Date Initiated by Firm | May 20, 2014 |
Date Posted | August 29, 2014 |
Recall Status1 |
Terminated 3 on August 14, 2017 |
Recall Number | Z-2337-2014 |
Recall Event ID |
68536 |
Product Classification |
Laparoscopy Kit - Product Code FDE
|
Product | LAPAROSCOPY GYN PACK -
(1) TABLE COVER REINFORCED 44" X 78"
(1) LAPAROSCOPY SHEET "T" SMS
(3) TOWELS ABSORBENT 15" X 20"
(1) SURGICAL BLADE#11 STAINLESS STEEL
(1) MAYO STAND COVER REINFORCED
(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK
(2) LEGGINS WITH 7" CUFF 30" x 42"
(1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35"
(4) DRAPE UTILITY WITH TAPE
(2) GOWN IMPERVIOUS REINFORCED LARGE SMS
(1) CONNECTING TUBING 3/16" X 12"
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
Code Information |
Product code 900-618, 24 lots: 109010109 109030609 109040846 109051047 109061208 109071536 109071688 109092073 109102337 112020491 112030732 112051999 112062499 112083436 112093647 113036805 113057495 113057617 113078338 113088878 113099446 113109861 140211734 140312178 |
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 | 24 lots; 648 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 |
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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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