| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2517-2014 |
| Recall Event ID |
68536 |
| Product Classification |
General surgery tray (kit) - Product Code LRO
|
| Product |
Chole Cystectomy All Endo System , code 900-3025, contains:
(1) TABLE COVER 44X 90 UF
(1) SYRINGE 20ccW/O NDL LUER LOCK LIF
(2) MAYO STAND COVER REINFORCED UF
(1) NEEDLE HYPODERMIC
(6) ABSORBENT TOWEL 15 X 20 UF
(1) NEEDLE HYPODERMIC 22G X 1Y. UF
(4) UTILITY DRAPE WIT APE UF
(1) TROCAR DILATING XCELL 5MM X 100
(3) GOWN XL SURGICAL MICROCOOL L/F
(1) TROCAR ENDOPATH XCEL DILATING TIP
(1) WRAPPER 24" X 24" UF
(1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF
(1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF
(5) APPLICATOR COTTON 6 WOOD UF
(1) ULTRA VERES NEEDLE 120MM LIF
(1) APPLIER MUL Tl CLIP W/SHAF GUN
(1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF
(2) DRAPE :Y. ECONOMY 53" X 77" UF
(2) UTLITY BOWL 16oz. UF
(1) SCALPEL WEIGHTED SAFETY #11 UF
(1) RING BASIN
(1) TIME OUT BEACON NON WOVEN UF
(1) TUBE SUCTION CONNECT
(1) MERLING SKIN PREP APPLIC 39ML UF
(1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF
(2) TOWEL CLOTH HUCK (BLUE) UF
(1 0) GAUZE SPONGE 4 X 4 16PL Y UF
(1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM
(5) LAP SPONGE PRE-WASH 18" X 18" XRD UF
(1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM
(1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF
(2) LIGHT SHIELD UF
(1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6
(1) DRAPE LASER CAMERA W/ELASTIC 6X 96
(1) PK. STERI STRIP CLOSURE
(1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF
(1) MAYO TRAY SMALL
(1) SYRINGE 30ML SLIP TIP 1 ML UF
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Code 900-3025, 1 lot: 131110114 |
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 |
1 lot/ 20 units |
| 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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