| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2435-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Accessories, operating-room, table (kit) - Product Code FWZ
|
| Product |
KNEE ARTHROSCOPY PACK
CONTENTS:
(1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE 4" X 4" 16PLY
(1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) SKIN MARKER INK W/8 LABEL
(2) TUBE SUCTION CONNECT. W X 12' LIF (1) CAST PADDING SOFT ROLL 6 X 4yds L/F
(2) BANDAGE ELASTIC 6" X 5yds L/F (4) STRIP TAPE 24" X 4" LIF
(1) Pk. STERI STRIP CLOSURE Y:z" X 4" LIF (1) SHEET ARTHROSCOPY "T" STD SMS
W/POUCH L/F
(5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) NEEDLE SPINAL ANESTHESIA 18G X 3% LIF (1) SYRINGE 10cc W/0 NDL L/LOCK LIF
(1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) GOWN IMPERV. XTRA REINF. LGE TIWRAP (1) MAYO STAND COVER REINFORCED LIF
(2) NEEDLE HYPODERMIC 25 X 1Y:z LIF
(1) TIME OUT BEACON NON WOVEN ST. LIF
(1) STOCKINETTE IMPERV. 14" X 48" LIF (1) TABLE COVER REINF. 50" X 90" LIF (1) SCALPEL WEIGHTED SAFETY #11
(1) SAFETY GLIDE NEEDLE 21G X 1%
(1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Product code 900-2123, 22 lots 112041293 112041377 112051685 112083162 112093925 112104110 112114603 113015564 113026273 113036460 113036691 113078467 113088788 113109787 131110236 131210645 140111094 140211658 140312117 140412557 140513124 140613657 |
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 |
22 lots/784 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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