Date Initiated by Firm | May 20, 2014 |
Date Posted | August 29, 2014 |
Recall Status1 |
Terminated 3 on August 14, 2017 |
Recall Number | Z-2499-2014 |
Recall Event ID |
68536 |
Product Classification |
Orthopedic tray - Product Code OJH
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Product | Knee Arthroscopy Pack, code 900-2718, contains:
(1 0) GAUZE SPONGES 4 X 4 12PL Y
(2) PADDING CAST SOFT ROLL 6 X 4yds.
(1) GOBAN SELF-ADHERENT WRAP 6 X 5yds
(3) PAD ABDOMINAL 8 X 7.5
(1) DRESSING 1 X 8 XEROFORM PETROLAT
(10) GAUZE SPONGES 4 X 4 16PLY XRD
(3) NEEDLE HYPODERMIC 18G X 1
(1) NEEDLE SPINAL ANESTH 18G X 3
(1) NEEDLE HYPODERMIC 22G X 1
(1) SYRINGE 30cc W/0 NEEDLE LUER LOCK
(1) SCALPEL W/HANDLE 11
(1) SKIN MARKER W/RULER
(9) LABELS FOR SKIN MARKERS
(1) RULER
(3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE
(1) BANDAGE ELASTIC KNIT STD 10yds
(1) BANDAGE ESMARK 6 X 9yds
(8) TOWELS CLOTH HUCK BLUE
(1) U - DRAPE 60 X 70 WIT APE SPLIT 6 X 21
(1) SHEET 60 X 77 DRAPE REINFORCED
(2) SOLUTION SURGICAL DURAPREP 26ML
(3) TUBE SUCTION CONNECT
(1) BOWL UTILITY 16oz.
(1) COVER TABLE REINFORCED 50 X 90
(2) GOWN SURGICAL REINFORCED X-LARGE
(1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP
(2) TOWELS ABSORBENT 15X 20
(1) STOCKINETTE IMPERV 12 X 48
(2) BAG PLASTIC 6 X 12
(1) KNEE ARTHROSCOPY DRAPE
(1) FILTER STRAW 5 MICRO
(2) LITE GLOVE
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
Code Information |
Code 900-2718: 3 lots 113026299 113068033 113078728 |
Recalling Firm/ Manufacturer |
Customed, Inc Calle Igualdad Final #7 Fajardo PR 00738
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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 | 3 lots/ 84 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 |
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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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