| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2431-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Angiography/angioplasty kit - Product Code OEQ
|
| Product |
ANGIOGRAPHY PACK
CONTENTS:
(4) CLOTH HUCK TOWEL BLUE
(1) TABLE COVER REINFORCED 50" x 90" LIF
(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF
(2) UTILITY BOWL 32oz LIF
(1) EMESIS BASIN 101N 700cc
(4) TOWEL CLAMP
(3) TOWELS ABSORBENT 15" x 20" LIF
(1) MOSQUITO HALSTED
(2) CHLORASCRUB SWABSTICK 5.1ML (1) PLATFORM TRAY LARGE
(1) SCALPEL SAFETY #11
(3) LABELS FOR SKIN MARKER
(1) LABEL F/MED. SALINE NORMAL BLUE (1) NEEDLE HYPODERMIC 18G X 1 Y2
(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 16oz
(4) BAND BAG WITH RUBBAND & TAPE LIF
(20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF
(1) FEMORAL ANGIOGRAPHY DRAPE WITH POUCH
(1) NEEDLE HYPODERMIC 21G X 1 Y2 (1) GOWN STANDARD SMS LARGE
(2) NEEDLE HYPODERMIC 23GA X 1"
(1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) LABEL FOR MEDICATION TRIDIL VIOLETA
(1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) WASH BASIN ROUND 6QT.
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Product code 900-2038, 21 lots: 112114658 112125063 113026054 113036790 113047157 113057456 113067865 113068044 113078304 113078602 113099284 113109785 131110231 131110604 131211016 131211023 140111450 140311934 140412464 140412897 140513123 |
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 differ 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 |
21 lots/ 1196 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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