| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2479-2014 |
| Recall Event ID |
68536 |
| Product Classification |
General surgery tray (kit) - Product Code OJH
|
| Product |
Hip & Knee replacement pack, 900-2614, contains
(1) CAUTERY TIP POLISHER UF
(1) BAG SUTURE FLORAL
(1) TUBE SUCTION CONNECT Y." X 12' UF
(1) TABLE COVER REINFORCED 50" X 90" UF
(1) MAYO STAND COVER REINFORCED UF
(5) TOWELS ABSORBENT 15" X 20" UF
(2) DRAPE SHEET 70" X 100" L/F
(5) LAP SPONGE PREWASH 18" X 18" XRD LIF
(1) SKIN STAPLE 35 WIDE LIF
(1) MAYO TRAY LARGE
(1) TOP DRAPE WITH ADHESIVE 100" X 50" SMS STD L/F
(1) BULB SYRINGE 60cc
(1) UTILITY BOWL 16oz
(1) UTILITY BOWL QUART 32oz
(1) INCISION DRAPE 23" X 17"
(1) SKIN MARKER WITH RULER
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21
(1) YANKAUER SUCTION TUBE WITHOUT VENT UF
(1) MERLING SKIN PREP APPLIC. 39ML UF
(1) BLADE SURGICAL# 10 STAINLESS STEEL
(1) SHEET SPLIT WITH ADHESIVE 108" X 77" UF
(1) *GLOVE# 7.5 SURGEON NEUTRALON LATEX
(1) * GLOVE # 8 SURGEON NEUTRALON LATEX
(1) *GLOVE# 8.5 SURGEON NEUTRALON LATEX
(3) GOWN IMPERVIOUS EXTRA REINFORCED XL LIF
(1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP
(4) UTILITY DRAPE WITH TAPE UF
(1 0) GAUZE SPONGE 4" X4" 16PL Y XRD LIF
(2) BANDAGE ELASTIC WITH VELCRO 6" X 5yds
(1) BLADE SURGICAL# 20 STAINLESS STEEL
(2) LITE GLOVE UF
(1) STOCKINETIE IMPERVIOUS 12" X 48"
(1) CAUTERY PENCIL ROCKER SWITCH UF
(1) BANDAGE ESMARK 6" X 9yds UF
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Product code 900-2614, 1 lot: 140312137 |
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 |
1 lot (30 packed units) |
| 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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