Z-1890-2013Class II
Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC...
Aso LLC / initiated 2013-07-26 / Terminated / root cause: packaging
ASO, LLC began a recall of Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used to secure, close and support... 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-1890-2013
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Aso LLC
- Product
- Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 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 #s: 175770 and 209340
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1888-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1889-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1890-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1891-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1892-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1893-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1894-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1895-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1896-2013 | Class II | Terminated | Voluntary: Firm initiated |
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