| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2375-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Neurological tray - Product Code OJG
|
| Product |
NEURO PACK -
(1) CAUTERY TIP POLISHER LIF
(4) DRAPE UTILITY WITH TAPE LIF
(1) INSTRUMENT POUCH
(10) LAP SPONGE PRE-WASH XRD
(1) Pk. SURGICAL STRIP W' X 6"
(2) UTILITY BOWL 32oz
(1) MAYO TRAY LARGE
(9) SHEET DRAPE 41 " X 69" MEDIUM LIF
(1) NEEDLE HYPODERMIC 18G X 1 LIF
(3) CONTAINER SPECIMEN 4oz WITH LID & LABEL
(2) Pr. SURGICAL GLOVES 7 Y2
(2) Pr. SURGICAL GLOVES 8
(2) EAR ULCER SYRINGE 2oz LIF
(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF
(1) SHEET MINOR LAP 102" X 121" X 78"
(1) SAFETY SCALPEL #10
(2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF
(4) CLOTH HUCK TOWELS BLUE
(1) PENCIL CAUTERY ROCKER SWITCH
(2) LEGGINS W/7'' CUFF 30" X 42"
(1) DRAPE% ECONOMY 53" X 77" LIF
(1) Pk. SURGICAL STRIP 'X" X 6"
(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF
(2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F
(2) ROUND WASH BASIN 6QT
(2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE
(2) Pr. SURGICAL GLOVES 7
(1) SKIN MARKER WITH RULER LIF
(1) Pk. STERI STRIP CLOSURE %"X 4" LIF
(1) TUBE SUCTION CONNECT. 'X" X 12' LIF
(1) SAFETY SCALPEL #15
(1) SAFETY SCALPEL #11L/F
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-1146, 36 lots: 109051127 110040868 110051198 110092116 110092352 110102423 111010024 111030547 111051146 111061483 111082046 111092345 111102659 111112945 111123320 112010025 112010277 112020314 112041069 112051672 112082330 112083209 112093735 112124923 113015489 113015687 113026040 113026202 113078237 131110156 131210626 140111140 140111777 140412582 140513068 140513475 |
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 |
36 lots; 936 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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