Recall Z-1642-2013— Surgical Instrument Service And Savings, Inc.

Name: FDA recall Z-1642-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-03

Class II · Terminated

Class II FDA medical device recall by Surgical Instrument Service And Savings, Inc., initiated 2013-05-03, terminated 2013-07-11. It names one FDA 510(k) clearance: K030179. Product: - 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 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 Phacofragmentation system.. 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..

Recalling firm: Surgical Instrument Service And Savings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-03
Terminated: 2013-07-11
Firm location: Redmond, OR, United States

510(k) clearances named in this recall

1 on FDA's record

K030179 — MEDISISS PHACOEMULSIFICATION TIPS/NEEDLESSurgical Instruments Service and Savings, Inc.·cleared 2003-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

- 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 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 Phacofragmentation system.

Reason for recall

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Data sourced from openFDA. This site is unofficial and independent of the FDA.