| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2502-2014 |
| Recall Event ID |
68536 |
| Product Classification |
General surgery tray (kit) - Product Code LRO
|
| Product |
REEMPLAZO DE RODILLA Y CADERA
CONTENTS:
(6) TOWELS ABSORBENT 15" X 20"
(I) PK. STRIP STERICLOSURE Y," X 4"
(I) COVER MAYO STAND RErNFORCED
(I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER
(I) BAG SUTURE FLORAL
(2) SCALPEL WEIGHTED SAFETY # I0
(I) STOCKrNETTE IMPERV 14" X 48"
(I) TIME OUT BEACON NON WOVEN
(2) DRAPE U 60" X 70"WI TAPE SPLIT 6" X 21 " (2) TUBE SUCTION CONNECT'/.'' X 12'
(2) DRAPE INCISE ANTIMICROBIAL 23" X 17"
(2) LIGHT SHIELD
(I) NEEDLE SPINAL ANESTH 18G X 3 Y,
(4) STR IPS TAPE 24" X 4"
(I ) GOWN IMP. XTRA REINF SMS XL T/W LEVEL
(20)GAUZE SPONGES 4" X 4" 16PLY
(3) DRAPE '!. ECONOMY 53" X 77"
(I) DRAPE UNDERBUTTOCK W/POUCI-1 44" X 35"
(I) DRAPE TOP WIADHESIVE 108" X 50" STD SMS
(I) COUNTER NEEDLE 60C FOAM STRIP/MAG STRIP
(I) YANKAUER OPEN TIP CLEAR W/0 CIV
(2) DRAPE SIDE 36" X 77" W/ADl-1.
(I) SHEET SPLIT W/ADHES 108" X 77" STD SMS
(I) SYRINGE 60ML UL W/0 NEEDLE
(I) POLISHER CAUTERY TIP
(I) NEEDLE BLUNT FILL 1 8G X I Y,
(2) COVER TABLE BTC 77" X I I 0"l-ID FULL COVERAGE
(2) GLOVE SURG. DERMA PRENE #8 POWDER FREE
(10) SPONGE LAP PREWASH 18" X 18" XRD
(I) COVER MAYO STAND W/CSR 23" X 54"
(I) BOWL UTILITY QUART 32oz.
(3) CLAMP TOWEL
(I) BOWL UTILITY PINT 16oz.
(3) GOWN MICROCOOL IMP. XTRA LONG XL
(3) BANDAGE ELASTIC 6" X 5YRD WIVELCRO
(I) MERLING SKrN PREP APPLIC.39ML
(2) PADDING CAST SOFT ROLL 6 X 4YRD
(I) MAYO TRAY LARGE
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Code 900-2726: 7 lots 131110255 131210799 140111086 140211664 140312141 140412664 140512992 |
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 |
7 lots,208 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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