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Class 2 Device Recall Polybond |
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Date Initiated by Firm |
April 03, 2007 |
Date Posted |
May 24, 2007 |
Recall Status1 |
Terminated 3 on August 01, 2008 |
Recall Number |
Z-0807-2007 |
Recall Event ID |
37756 |
510(K)Number |
K001172
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Product Classification |
suture - Product Code GAT
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Product |
Product is an EO Sterile, Polyester braided and coated nonabsorbable surgical suture with double needle, size 2/0 (3.0 Metric), NSH 26 mm TAPER Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped.
Product overwrap label includes: '2/0 (3.0 metric) CP523A Polybond Green Braided, Polyester Coated Nonabsorbable Sterile Suture Rx Only TAPER NSH 36' (90cm) 1/2 26mm Manufactured by CP Medical Portland, OR USA'.
Product box label includes: '2/0 (3.0 metric) CP523A NSH 26 mm 1/2 TAPER POLYBOND Green Polyester Braided Coated Nonabsorbable 36' (90cm) STERILE EO Manufacturer CP Medical Portland, OR USA' .
Product was distributed to single consignee, a distributor in South Africa. |
Code Information |
Product label is coded CP523A. Lot numbers include: I0625120 expiration 2011-08, and I0627120-01 expiration 2011-08. |
Recalling Firm/ Manufacturer |
C P Medical 803 Ne 25th Ave Portland OR 97232
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For Additional Information Contact |
Madalyn C. Duncan 503-445-1619
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Manufacturer Reason for Recall |
Potential for sterility of product to be compromised. Suture package seals incomplete or missing.
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FDA Determined Cause 2 |
Other |
Action |
On 04/03/2007 the firm notified its Polyester product (Polybond) customer by telephone and followed up on 04/09/2007 with a letter via certified mail requesting the distributor to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/09/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical.
On 04/20/2007 the firm notified its Polypropylene and Polydioxanone product customers by letter dated 04/17/2007 via certified mail requesting distributors to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/18/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical. |
Quantity in Commerce |
121 boxes (12/box) Lot I0625120, and 121 boxes (12/box) Lot I0627120-01 |
Distribution |
Firm distributes products to human and veterinary medical device distribution centers worldwide.
Polybond Polyester sutures, product CP523A, were distributed to one distribution center in South Africa.
Polypropelene sutures, product 8665, were distributed to veterinary distribution centers in OH, OR, and NE for nationwide distribution.
Polydioxanone sutures, product M398A, were distributed to human and veterinary distribution centers in AZ, IA, OH, LA, MA, MI, MO, NE, and TX for nationwide distribution. |
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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510(K) Database |
510(K)s with Product Code = GAT and Original Applicant = CP MEDICAL
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