| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2512-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Orthopedic tray - Product Code OJH
|
| Product |
TLIF PACK
SURGICAL CENTER, CODE 900-2918.
CONTENTS:
(2) SOLUTION SURGICAL DURAPREP 26ML UF
(6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF
(4) GOWN SOFT SMS STD XL SET IN SLEEVE UF
(4) TOWELS ABSORBEN 15" X 20" LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF
(1) MAYO STAND COVER REINFORCED LIF
(4) DRAPE% 60" X 76" REINFORCED L/F
(1) DRAPE CHEST 100" X 142" X 72" LIF
(1) FLUORO COVER 30" X 30" WITH RUBBBAND LIF
(2) LITE GLOVE LIF
(2) TUBE SUCTION CONNECT. Y." X 12' UF
(12) TOWELS CLOTH HUCK BLUE LIF
(1) UTILITY BOWL QUART 32oz
(10) GAUZE SPONGE 4" X 4" 16PLY XRD UF
(5) LAP SPONGE PREWASH 18" X 18" XRD LIF
(1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER LIF
(1) STERI STRIP DRAPE LARGE 17" X 23" LIF
(1) SKIN MARKER WITH RULER UF
(9) LABELS FOR SKIN MARKERS 1.25 X Y2
(1) RULER
(1) NEEDLE & BLADE COUNTER 20C FOAM/MAG L/F
(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF
(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF
(1) BULB SYRINGE 60cc LIF
(4) NEEDLE HYPODERMIC 18G X 1Y2 UF
(1) NEEDLE HYPODERMIC 22G X 1Y2 LIF
(2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK UF
(1) NEEDLE SPINAL 18G X 6" LONG LENGTH LIF
(1) BLADE SURGICAL # 10 CARBON STEEL
(1) BLADE SURGICAL # 15 CARBON STEEL
(1) TIME OUT BEACON NON WOVEN UF
(2) DRESSING TEGADERM 4" X 4% "UF
(2) MEDICINE CUP 2oz
(1) DRAPE IOBAN INCISE 2 ANTIMICROBIAL 23" X 23" LIF
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Code 900-2918, 8 lots 113047023 113057703 113068037 113078429 113078733 113109799 140312147 140613795 |
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 |
8 lots, 273 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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