| Date Initiated by Firm | May 20, 2014 |
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| Date Posted | August 29, 2014 |
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| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number | Z-2402-2014 |
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| Recall Event ID |
68536 |
| Product Classification |
General surgery tray (kit) - Product Code LRO
|
| Product | UNIVERSAL PACK -
(1) TRAY ORGANIZER FULL DEEP
(1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF
(1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF
(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF
(1) NEEDLE HYPODERMIC 20G X 1 ~ UF
(2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill
(1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF
(1) SHEET% 57" X 63" REINFORCED SMS LIF
(2) TOWELS ABSORBENT 15" X 20" LIF
(4) DRAPE UTILITY LIF
(1 0) GAUZE SPONGES 4" X 4" 12PL Y LIF
(4) CLOTH HUCK TOWELS BLUE LIF
(1) TABLE COVER REINFORCED 50" X 90" UF
(1) SCALPEL WITH HANDLE #11
(1) DENTURE CUP WITH LID
(1) TRAY 2 COMPARTMENT
(2) ABSORBENT TIP APPLICATOR
(1) IMPERVIOUS STOCKINETIE 14" X 48" LIF
(1) TAPE TRANSPORE 1" X 36"
(1) DIISP NEEDLE 30 X ~
(1) PROBE DRAPE 6" X 96 WITH GEL
(1) ARTERIAL NEEDLE 18 X 2 %
(1) CATHETER INTRODUCER 7FR
(1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
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| Code Information |
Product code 900-1587, 36 lots: 102030623 110082155 110082298 110102430 110112610 110122922 111010202 111020362 111030586 111040993 111051366 111061501 111071771 111082193 111092502 111102687 111113016 111123356 112010065 112020382 112041190 112051845 112062430 112072709 112083158 112083400 113015504 113025773 113036453 113036751 113067890 113089195 113099383 131110184 140111159 140312077 |
Recalling Firm/
Manufacturer |
Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
|
| For Additional Information Contact | Rosemari Melendez
787-622-5151 Ext. 7540 |
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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. |
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FDA Determined
Cause 2 | Package design/selection |
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| 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 |
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| Quantity in Commerce | 36 lots; 888 units (multiple units per lot) |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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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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