| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2421-2014 |
| Recall Event ID |
68536 |
| Product Classification |
General surgery tray (kit) - Product Code LRO
|
| Product |
UNIVERSAL PACK -
(1) UTILITY BOWL 16oz.
(1) NEEDLE SPINAL ANEST. 22G X 31!2
(1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF
(2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF
(1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF
(1) NEEDLE HYPODERMIC 20G X 1 1!2
(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII
(1) SPLIT SHEET WITH ADHESIVE 108" X 77" SMS STD LIF
(1) DRAPE % ECONOMY 53" X 77" UF
(2) TOWEL ABSORBENT 15" X 20" UF
(4) DRAPE UTILITY WITH TAPE LIF
(1 0) GAUZE SPONGES 4" X 4" 12PL Y
(4) TOWELS CLOTH HUCK BLUE
(1) TABLE COVER REINFORCED 50" X 90" UF
(1) SCALPEL WITH HANDLE #11
(3) PK. CLOSURE SKIN W' X 4" STERI STRIP UF
(1) SKIN MARKER WITH RULER
(1) DENTURE CUP 8oz WITH LID
(1) NEEDLE HYPODERMIC 25 X 1 1!2
(1) STOCKINETTE IMPERVIOUS 14" X 48"
(2) TIP ABSORB. APPLICATOR STICK SPONGE
(1) TRAY ORGANIZER FULL DEEP
(1) TRA 2/COMPARTMENT
(1) RULER L/F
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Product code 900-1936, 22 lots: 110082088 110082207 110102439 110112627 110112928 111010082 111030630 111041100 111051372 111061520 111071785 111113056 111123422 112010103 112041214 112062469 112083415 113109769 131210637 140111090 140312098 140412891 |
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; 312 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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