• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HEB Wound Closure Adhesive Surgical Tape Strips

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
HEB Wound Closure Adhesive Surgical Tape Strips
see related information
Date Posted August 06, 2013
Recall Status1 Open
Recall Number Z-1891-2013
Recall Event ID 65819
Product Classification Closure, Wound, Adhesive - Product Code MGO
Product HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.
Code Information ASO Packaging Lot #s: 143560, 171871, 250861, 379061, 402860, 418910, 513820, and 544130
Recalling Firm/
Manufacturer
ASO, LLC
300 Sarasota Center Blvd
Sarasota, Florida 34240-9381
For Additional Information Contact Michelle Pulaski
888-364-7004 Ext. 146
Manufacturer Reason
for Recall
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action ASO sent a letter on July 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine your inventory and stop using/distributing the product. Place in quarantine to be returned or destroyed. ASO customers will receive credit for returned product or a returned completed Certificate of Destruction. Please use Return Authorization Number 1675 when returning the product. Please complete and return the enclosed response form as soon as possible. Return the form to: Address: ASO LLC Regulatory Affairs 300 Sarasota Center Blvd. Sarasota, FL 34240 Fax: 941-378-9040 Attn: Regulatory Affairs For questions regarding this recall call 888-364-7004, ext 146.
Quantity in Commerce Total 2,689,560 pouches (2 cards/pouch)
Distribution Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-