| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2368-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Accessories, operating-room, table (kit) - Product Code FWZ
|
| Product |
ARTHROSCOPY PACK -
(1) SURGICAL DURAPREP SOLUTION 26ML LIF
(1) ESMARK BANDAGE
(1 ) ELASTIC BANDAGE 6" X 5yds LIF
(1) NEEDLE & BLADE COUNTER 20C FOAM/MAG
(1) TUBE SUCTION CONNECTING W X 12' LIF
(1) SHEET EXTREMITY ABS. 125" X 85" SMS
(1) DRAPE LASER CAMERA W/EL
(3) TOWELS ABSORBENT 15" X 20" LIF
(2) CONTAINER SPECIMEN 4oz. WITH LID & LABEL
(1) BABY BLANKET IMP. POLY ABS. LIF
(1) NEEDLE HYPODERMIC 20G X 1%''
(10) GAUZE SPONGES 4" X 4" 16PLY
(1) BLADE SURGICAL #11 CARBON STEEL
(1) TABLE COVER REINFORCED 50" X 90" LIF
(1) IMPERVIOUS STOCKINETTE
(1) SHEET DRAPE 42" X 55" LIF
(1) SUTURE BAG FLORAL LIF
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT
(1) MAYO STAND COVER REINFORCED LIF
(2) GOWN IMPERVIOUS REINFORCED SMS LARGE
(4) STRIPS TAPE
(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF
(1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y
(1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL & WRAP
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-1042, 12 lots: 113026163 113036737 113046994 113057378 113078232 113078669 113089153 113109704 131110065 131110610 140111137 140312045 |
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 |
12 lots; 432 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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