| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2454-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Hysterectomy kit - Product Code OJF
|
| Product |
TOTAL HYCTERECTOMY
(I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM
(I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF
( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF
(I) DRAPE VIDEO CAMERA 13cm X 244 em LIF
( I ) DRAPE LAP ABDOM W/POUCH 1 02" X 1 22" X 78" STD SMS
(2) LEGGINGS W/7" CUFF 30'' X 42" ( I ) SAFETY SCALP EL # II S/STEEL
( I ) GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III ( I ) TABLE COY ER REINFORCED 50" X 90" LIF
(4) DRAPE UTILITY WIT APE LIF
(2) DRAPE SI-IEET 42" X 57" SMS
(I) TUBE SUCTION CONNECT Y." X 1 2' LIF
( I ) MAYO STAND COYER REINFORCED LIF (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF
(2) LITE GLOVE
( I ) DRAPE UNDERBUTTOCK W/ PO UCl-144" X 35" (2) SYRINGE I Occ W/0 NEEDLE LILOCK LIF
(2) SPEC IMEN CONTA INER 4oz W/LID & LABEL (1 5) LAP SPONGE PREWASH 18'' X 1 8" XRD LIF
( I ) PVP PAINT 8" STICK SPONGE
( I ) UTILITY BOWL QUART 32oz LIF ( I ) ELECTRODE DUAL DEPRES
( I) DRESSING OPSITE POST PO 2!12 X 2"
( I ) MERLINO SK IN PREP APPLIC. 39ML LIF
(3) GOWM XL SMS IMPERVIOUS REINFORCED LIF
( I ) CORD LAPAROSCOPY MONOPOLAR FOOD SWICH ING
(1) FOLEY CATHETER KIT CONTAINING:
(I) CATHETER 1 6FR FOLEY 2WAY, Sec
(I) PYP TR IPLE SWABSTICK IODOPHOR (2) SWABSTICK DRY COTTON
( I ) SYR I NGE IOcc WATERFREFIL LIF
(2) GLOVE MED FREETOUCH YYN I L P/F (I) TOWEL3PLYPOLY 17" X 18"
(I) DRAPE 4" FENESTRATED 18" X 26" (I) LABEL lD PATIENT
(I) JELLY LUBRI CATING FIVE GRAM
( I ) URINARY BAG DRAINAGE 2000ML ANTI-REFLUX LIF ( I ) TRAY SBS
( I ) WRAPPER 24" X 24"
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Product code 900-2415 ,1 lots 140412654 |
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 ,6 units placed on hold at the firm |
| 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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