| 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-2440-2014 |
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| Recall Event ID |
68536 |
| Product Classification |
laparoscopy kit - Product Code FDE
|
| Product | LAPAROSCOPY PACK
CONTENTS:
( I ) BULB SYRINGE 60cc LIF
( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF
( I ) MAYO STAND COYER REINFORCED LIF
( I ) TABLE COVER REINFORCED 50" X 90" LIF
(3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LIF
( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF
(3) LITE G LOVE LIF
( I ) DRAPE LAP ABDOM. WI POUCH 102" X 122" X 78"
( I ) BLADE SURG ICA L # II STAIN LESS STEEL
( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF
( I ) SUTURE BAG FLORAL
(I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1'
( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF
(2) DRESSING NON ADH TELfoA 4 X 3
( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL
(2) SH EET 'll.o 60" X 77" DRAPE R EI NFORCED LIF
( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF
( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF
( I ) WRAPPER 24" X 24"
(2) DENTURE CUP 8oz WILID
ADHERED OUTSIDE OF THE PACK INTO A POUCH:
( I ) NEEDLE ULTRA VERES 1 20MM LIF
( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT)
( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT)
( I ) CANNU LA 5MM XCEL SLEEVES LIF
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
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| Code Information |
Product code 900-2204, 5 lots 112050723 112062283 112083422 112093930 112125070 |
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 | 5 lots/214 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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