| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2392-2014 |
| Recall Event ID |
68536 |
| Product Classification |
General surgery tray (kit) - Product Code LRO
|
| Product |
UMBILICAL VESSEL CATHETER KIT - CUSTOMED-
(1) PAPER TAPE MEASURE DISP. 24"
(1) FENESTRATED DRAPE 18" x 26" LIF
(1) NEEDLE HOLDER BAUMGARTNER 5"
(2) HALSTED MOSQUITO CVD 5" SERRAT
(1) ADSON FORCEP TISS. Wff
(1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF
(6) GAUZE SPONGE 2" X 2" 8PL Y
(6) GAUZE 4" X 4" 16PL Y
(1) SYRINGE 1 cc TB SffiP
(1) IRIS FORCEP SERR Y. CVD 4" WITH PROTECTOR TIP
(1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP
(1) SUTURE 3-0 BLK MONOFIL
(1) TRAY ORGANIZER FULL DEEP
(1) WRAPPER 30" X 30" L/F
(1) PVP TRIPLE IODOPHOR SWABSTICK
(1) TONGUE DEPRESSOR 6" WOOD
(1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP
(1) SCALPEL WITH HANDLE #11
(1) MOSQUITO FORCEP STRAIGHT 5"
(2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF
(2) 3 PLY POLY TOWEL
(1) UMBILICAL TAPE
(1 ) PROBE GRONED & DISNEETNS 6" 2ML
(1) EYE DRESSING EXT FINE POINT FULL
(2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO
(1) PLASTIC TRAY 2/COMPARTMENT
(1) HALF TRAY
(1) STOPCOCK 3 WAY LUER SLIP
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-1408, 7 lots: 113015546 113057835 140211780 140412600 140513084 113047152 112051753 |
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 |
7 lots; 176 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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