Date Initiated by Firm | May 20, 2014 |
Date Posted | August 29, 2014 |
Recall Status1 |
Terminated 3 on August 14, 2017 |
Recall Number | Z-2371-2014 |
Recall Event ID |
68536 |
Product Classification |
Accessories, operating-room, table (kit) - Product Code FWZ
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Product | ARTHROSCOPY PACK-
(1) VIDEO CAMERA DRAPE 13cm X 244cm LIF
(2) BANDAGE ELASTIC 6" X 5yrd. LIF
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT
(1) DURAPREP SURGICAL SOLUTION 26m I LIF
(1) STOCKINETIE IMPERVIOUS
(1) TUBE SUCTION CONNECT. 3/16" X 12' LIF
(1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF
(1) BAG SUTURE FLORAL LIF
(1) BLADE SURGICAL #11 CARBON STEEL
(2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF
(1) SYRINGE 30cc SLIP TIP LIF
(1) TABLE COVER 44" x 90"
(1) MAYO STAND COVER REINFORCED LIF
(4) TOWELS ABSORBENT 15" X 20" LIF
(5) LAP SPONGES PRE-WASH XRD UF
(1) DRAPE SHEET 41 " x 58" SMS UF
(1) NEEDLE HYPODERMIC 22G X 1 Y:z
(1) NEEDLE HYPODERMIC 18G X 1 Y:z
(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF
(10) GAUZE SPONGES 4" X 4" 16PL Y
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
Code Information |
Product code 900-1062, 16 lots: 109071569 112072765 112083154 113057380 113057684 113057854 113078233 113078670 113089154 113099586 131110151 131110593 131210956 140412452 140513063 140513390 |
Recalling Firm/ Manufacturer |
Customed, Inc Calle Igualdad Final #7 Fajardo PR 00738
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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 | 16 lots; 512 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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