StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138
This recall has been terminated (originally issued December 14, 2005).
- Company
- Stryker Endoscopy
- Recall Initiated
- November 18, 2005
- Posted
- December 14, 2005
- Terminated
- November 2, 2006
- Recall Number
- Z-0279-06
- Quantity
- 48405 boxes, 6 units per box
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Devices for which sterility may be compromised as evidenced by a crack in the package.
Distribution
The product was distributed nationally to 1321 consignees and internationally to 18 consignees.
Lot / Code Info
Lots 05258FG2 through 05299FG2; ***On 1/6/06 Lot Code bracket expanded: 05151FG2 through 05299FG2***
Root Cause
Other
Action Taken
On 11/18/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
More recalls by Stryker Endoscopy
PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator;
High pressure units (HPU...
Mar 28, 2016
SERFAS 90 degree Energy Probe, Part Number 279-350-101;
SERFAS Energy Probes are indicated for arth...
Jun 24, 2015
PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080047
Laparoscopic Manual Instruments are intended for cu...
Dec 12, 2014