| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2366-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Cesarean section kit - Product Code OHM
|
| Product |
C-SECTION PACK -
(1) TABLE COVER REINFORCED 50" X 90" L/F
(3) TOWELS ABSORBENT 15" X 20" L/F
(1) BABY BLANKET
(1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF
(1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV
(2) PAD OBSTETRICAL XL LIF
(1) LITE GLOVE LIF
(1) DRAPE SHEET 41" X 69" MEDIUM LIF
(2) SURGICAL BLADE #10 CARBON STEEL
(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF
(1) BAG GLASSINE
(2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR
(1) CONTAINER 64oz WITH LID
(1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF
(1) MAYO STAND COVER REINFORCED UF
(1) BAG SUTURE FLORAL
(15) LAP SPONGES PRE-WASH XRD LIF
(1) EAR ULCER SYRINGE 2oz UF
(1) CORD UMBILICAL CLAMP L/F
(1) WASH BASIN ?QT.
(1) CAUTERY TIP POLISHER LIF
(1) YANKAUER SUCTION TUBE W/0 VENT LIF
(1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78"
(1) FEEDING TUBE 8FR. 15" LONG
(4) DRAPE UTILITY WITH TAPE UF
(1) TUBE SUCTION CONNECT. Y." X 12' UF
(2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-998, 30 lots: 110102460 110112688 110123134 111010177 111020380 111040983 111051307 111061695 111071843 111082122 111092412 111092562 111102894 111123312 111123473 112020498 112030759 112041367 112072882 112083446 112093766 112114689 112125126 113026063 113036770 113078482 113109886 140111264 140311950 140412910 |
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 |
30 lots; 1392 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.
|
