| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2396-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Angiography/angioplasty kit - Product Code OEQ
|
| Product |
ANGIOGRAPHY PACK -
(1) LINE H.P. 1200 PSI 48" M/F
(1) ANG. FEMORAL DRAPE WITH POUCH UF
(1) PLATFORM TRAY LARGE
(3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF
(2) BAG BAND RUBBAN & TAPE UF
(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF
(5) ABSORBENT TOWELS 15" X 20" LIF
(1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF
(1) SURGICAL DURAPREP SOLUTION 6ML LIF
(1) SAFETY SCALPEL #11 STAINLESS STEEL
(2) GOWN STANDARD SMS LARGE VELCRO NECK
(1) MANIFOLD WITH CONTROL SYRINGE
(1) NEEDLE 18G X 2% AMC/4
(2) UTILITY BOWL 16oz UF
(2) CLOTH HUCK TOWEL BLUE
(2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF
(2) MEDICINE CUP 2oz LIF
(30) GAUZE SPONGE 4" X 4" 16PL Y
(1) NEEDLE HYPODEMIC 18G X 1 ~
(4) TOWEL CLAMP
(2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF
(1) HALSTED MOSQUITO CVD 5" SERRAT
(2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F
(2) NEEDLE HYPODERMIC 22G X 1
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-1488, 16 lots: 111123348 112010051 112020372 112030619 112041075 112072775 112104146 112124636 112124951 113025839 113026046 113036412 113078257 131210748 140211642 140412601 |
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 |
16 lots; 570 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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