Recall Z-1642-2013 ยท NKX Needle, Phacoemulsification, Reprocessed
Surgical Instrument Service And Savings, Inc.
- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics Mini-Flared ABS Tip, 20 Degree Tip Angle, 45 Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics Tapered ABS MicroTip" 30 Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 Series 20000" Legacy TurboSonics Flared ABS MicroTip, 30 De
| Date | Jul 1, 2013 (initiated May 3, 2013) |
| Status | Terminated |
| Reason | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| Root cause | Packaging process control |
| Action | MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales r |
| Quantity | 90 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030179 | MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES Surgical Instruments Service and Savings, Inc., Jan 24, 2003 |