Date Initiated by Firm | May 20, 2014 |
Date Posted | August 29, 2014 |
Recall Status1 |
Terminated 3 on August 14, 2017 |
Recall Number | Z-2338-2014 |
Recall Event ID |
68536 |
Product Classification |
laparoscopy kit - Product Code FWZ
|
Product | ARTHROSCOPY PACK -
(1) MAYO STAND COVER REINFORCED LIF
(1 0) GAUZE SPONGES 4" X 4" 16PL Y
(1) TUBE SUCTION CONNECTING X" X 12' LIF
(1) IMP. STOCKINETTE
(1) SURGICAL BLADE #11 STAINLESS STEEL
(1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~
(1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUER LOCK LIF
(2) ELASTIC BANDAGE 6" X 5yrd LIF
(1) TUR Y SET 81 "2.1m REGULAR CLAM
(2) NEEDLE HYPODERMIC 18G X 1 ~
(1) TABLE COVER 50" X 90" REINFORCED LIF
(5) TOWEL ABSORBENT 15" X 20" LIF
(2) DRAPE UTILITY WITH TAPE LIF
(1) DURAPREP SURGICAL SOLUTION 26m I LIF
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT
(1) Pr. NEUTRALON SURGEON GLOVES #7.5
(1) Pr. NEUTRALON SURGEON GLOVES #8
(1) Pr. NEUTRALON SURGEON GLOVES #8.5
(2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS
(10) GAUZE SPONGES 4" X 4" 16PLY XRD
(2) STRIPS TAPE
(1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF
(1) DRAPE VIDEO CAMERA LIF
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
Code Information |
Product code 900-620, 28 lots: 111113132 111123276 112010192 112020517 112030733 112041340 112052000 112062500 112072808 112083437 112093729 112114579 112124875 113015455 113025964 113036374 113036444 113068176 113088879 113099447 113109862 131210833 140111241 140211733 140211943 140412839 140513377 140513456 |
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 | 28 lots; 2620 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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