Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1889-2013Class II

Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free...

Aso LLC / initiated 2013-07-26 / Terminated / root cause: packaging

ASO, LLC began a recall of Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and... on . FDA classified it as Class II and gives the reason as "This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1889-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Aso LLC
Product
Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and support small cuts and wounds.
Product code
MGO Closure, Wound, Adhesive
Reason for recall
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Root cause tag
packaging
FDA root cause
Package design/selection
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.
Product codes and lots
ASO Packaging Lot #: 208351

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1889-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1888-2013Class IITerminatedVoluntary: Firm initiated
Z-1889-2013Class IITerminatedVoluntary: Firm initiated
Z-1890-2013Class IITerminatedVoluntary: Firm initiated
Z-1891-2013Class IITerminatedVoluntary: Firm initiated
Z-1892-2013Class IITerminatedVoluntary: Firm initiated
Z-1893-2013Class IITerminatedVoluntary: Firm initiated
Z-1894-2013Class IITerminatedVoluntary: Firm initiated
Z-1895-2013Class IITerminatedVoluntary: Firm initiated
Z-1896-2013Class IITerminatedVoluntary: Firm initiated