Recall Z-0560-2007
Alcon Laboratories, Inc · initiated December 22, 2006
Product
Alcon Custom-Pak, part #10975-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
Codes / lots: Lot #649244H.
Reason for recall
Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
FDA-determined cause: Other
Action taken
Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level.
Details
- Recall number
- Z-0560-2007
- Initiated
- December 22, 2006
- Posted by FDA
- March 1, 2007
- Terminated
- June 6, 2007
- Product code
- HNN – Knife, Ophthalmic
- Quantity
- 4 custom surgical packs.
- Distribution
- Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
- Recalling firm
- Alcon Laboratories, Inc, Houston, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0561-2007 | Alcon Custom-Pak, part #2638-17, containing BD Beaver Mini-Blade (part #BD6400 or part…Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for… | 12/22/2006Terminated |
| Z-0562-2007 | Alcon Custom-Pak, part #4917-54, containing BD Beaver Mini-Blade (part #BD6400 or part…Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for… | 12/22/2006Terminated |
| Z-0563-2007 | Alcon Custom-Pak, part #6515-51, containing BD Beaver Mini-Blade (part #BD6400 or part…Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for… | 12/22/2006Terminated |
| Z-0564-2007 | Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part…Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for… | 12/22/2006Terminated |