| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2352-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Angiography/angioplasty kit - Product Code OEQ
|
| Product |
FEMORAL ANGIOGRAPHY PACK -
(1) TABLE COVER REINFORCED 50" X 90" UF
(1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF
(1) TOWEL ABSORBENT 15" X 20" UF
(1) DRAPE ANGlO 75" X 145"
(4) TOWELS CLOTH HUCK (BLUE) UF
(3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF
(1) IV ADM SET 15ML 1 06" LONG LIF
(20) GAUZE SPONGE 4" X 4" 12PL Y LIF
(1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF
(1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF
(2) MEDICINE CUP 2oz. CLEAR LIF
(1) SCALPEL WEIGHTED SAFETY #11
(2) CHLORASCRUB SWABSTICK 5.1 ML LIF
(1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF
(1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF
(1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF
(1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF
(1) FORCEP ADS ON TISS. WITH TIP LIF
(1) UTILITY BOWL 32oz LIF
(1) UTILITY BOWL 16oz L/F
(1) FORCEP KELLY STRAIGHT 5.5" LIF
(1) MOSQUITO HALSTED CVD 5" LIF
(1) TRAY ORGANIZER FULL DEEP LIF
(1) SCISSOR MAYO 6.75 STRAIGHT LIF
(1) HOLDER NEEDLE WEBSTER 4.75 LIF
(1) GUIDEWIRE .035" X 150cm UF
(1) TIME OUT BEACON NON WOVEN ST. UF
(1) MAYO TRAY SMALL LIF
(2) TOWEL CLAMP UF
(2) BAG BAND RUBBAND & TAPE LIF
(1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF
(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF
LABEL SAMPLE
(1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF
(1) NEEDLE 18G X 2 o/.i AMC/4
(1) SKIN MARKER INK WITH/8 LABEL
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Product code 900-796, 14 lots: 113047032 113057507 113067965 113078346 113088892 113109873 131110279 131210842 140111251 140211700 140311949 140312388 140513145 140513340 |
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 |
14 lots; 580 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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