Recall Z-1221-2013
Stryker Endoscopy · initiated March 27, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Codes / lots: Manufacturer Part Number:250-070-407
Reason for recall
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.
FDA-determined cause: Error in labeling
Action taken
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Details
- Recall number
- Z-1221-2013
- Initiated
- March 27, 2013
- Posted by FDA
- May 3, 2013
- Terminated
- September 24, 2013
- Product code
- GCX – Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- Quantity
- 147,921 - all sizes
- Distribution
- Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.
- Recalling firm
- Stryker Endoscopy, San Jose, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1218-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1219-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1220-2013 Class II | Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1222-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1223-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1224-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1225-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1226-2013 Class II | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1227-2013 Class II | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1228-2013 Class II | Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1229-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1230-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1231-2013 Class II | Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1232-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1233-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1234-2013 Class II | Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30 Downward…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1235-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1236-2013 Class II | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |
| Z-1237-2013 Class II | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | 03/27/2013Terminated |