| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2324-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Obstetrical kit - Product Code OKV
|
| Product |
LABOR & DELIVERY PAC -
1) NEEDLE HYPODERMIC 18G X 1% ST.
(2) DRAPE UNDERBUTTOCK WITH POUCH
(4) TOWELS ABSORBENT 15" X 20"
( 1) FEEDING TUBE 8FR, 15" LONG
( 1) BEANNIES BABY
( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK
( 1) UMBILICAL CORD CLAMP ST.
( 1) RECEIVING BLANKET 100% COTTON
( 1) TOWELS CLOTH HUCK (BLUE)
(2) LEGGINGS W/7" CUFF 30" X 42"
( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV.
( 1) BOWL PLASTIC 80oz
( 1) LID FOR BOWL 80oz CLEAR
(20) GAUZE SPONGE 4" X 4" 16PLY
(2) PAD OBSTETRICAL X-LARGE ST.
( 1) PACKING VAGINAL XRD 4 X 36 8PLY
( 1) TABLE COVER REINFORCED 50" X 90"
( 1) DRAPE ABDOMINAL WITH TAPE 40" X 54"
(1 ) NEEDLE HYPODERMIC 21G X 1% ST.
(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK
(2) PVP SCRUB 8" STICK SPONGES ST.
( 1) EAR ULCER SYRINGE 2oz.
( 1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED
(2) WRAPPER 30" X 30"
( 1) PVP PAINT 8" STICK SPONGE ST.
(2) GLOVE SURG DERMA PRENE #7 % PF
(1) TIME OUT BEACON NON WOVEN ST.
(1) VACUTAINER GREEN NAHEP 10ML
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents |
| Code Information |
Product code 900-419, 16 lots: 112041449 112093941 112114601 113025847 113026169 113036364 113047313 113067871 113078327 113089073 113099292 131110077 131210815 140111228 140211670 140311939 |
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 |
16 lots; 1852 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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