| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2397-2014 |
| Recall Event ID |
68536 |
| Product Classification |
laparoscopy kit - Product Code FDE
|
| Product |
D & C LAPAROSCOPY PACK -
(1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT
(1) MAYO STAND COVER REINFORCED UF
(4) DRAPE UTILITY UF
(1) TRAY MAYO SMALL LIF
(1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL
(1) SUTURE BAG FLORAL LIF
(1) TUBE SUCTION CONNECT X" X 12' LIF
(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF
(2) LEGGINGS WITH 7" CUFF 30" X 42" LIF
(1) UTILITY BOWL 32oz. UF
(1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX
(2) DRESSING NON ADH TELFA 4 X 3 ST. UF
(1) JELLY LUBRICATING FIVE GRAM
(1) TABLE COVER REINFORCED 50" X 90" LIF
(1) *Pk. STERI STRIP LAP SET LATEX
(1) COVER CAMERA W/ELAST UF
(2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF
(4) TOWELS ABSORBENT 15" X 20" UF
(1) DRAPE LAP. PERINEAL WITH POUCH 102" X 97" SOFT SMS UF
(2) LIGHT SHIELD
(1) DRESSING TEGADERM 4" X 4 %" LIF
(10) GAUZE SPONGE 4" X 4" 16PLY XRD UF
(1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP
(1) SCALPEL WEIGHTED SAFETY #11
(1) BAG ZIP LOCK
(1) Pk. STRIP STERI CLOSURE W' X 4" LIF
(1) TIME OUT BEACON NON WOVEN ST. UF
(1) BANDAGE GAUZE STRETCH 4"
(1) NEEDLE ULTRA VERES 120MM UF
(2) COUNTER NDUBLADE, 10C MAG/CLEAR UF
(1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER L/F
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-1496, 22 lots: 112041078 112051677 112062422 112114953 113015550 113025817 113026047 113036320 113036750 113057690 113067952 113088734 113099274 113109735 131110178 131210749 140111077 140211644 140311921 140412602 140513092 140513391 |
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; 968 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.
|
