Recall Z-0623-2015
Stryker Endoscopy · initiated November 17, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
Codes / lots: 42358 42361 44292 44306 102110 1092012 123010 140323 140337 0200294C 2092012 2172014 0245175C 0245377C 0245381C 0245820C 0245821C 0245832C 0245891C 0246317C 0246318C 0246930C 0247039C 0247041C 3122014 0341227C 0341901C 0344750C 04192012E 04232013E 42499 04262013D 0442448C 0442451C 0442454C 0442457C 0442458C 0442460C 0442463C 0442465C 0442466C 0442467C 0442470D 05102011E 5132010 5262010 0541369D 0541374D 0541377D 0541381D 0541388D 0541390D 0541392D 0541393D 6022014 6142014 06182012E 6202014 6222014 6232014 0640125D 0640129D 0640131D 0640132D 0640133D 0640135D 0640137D 0640138D 0640140D 0640141D 0640146D 0640906D 0643123D 0643124D 0643125D 0643126D 0643127D 0643128D 0643130D 0643131D 0643134D 0643135D 0643136D 0643137D 0643138D 0643139D 0643140D 0646331D 0646997D 646998 0646998D 0646999D 0647000D 0647001D 0647002D 0647004D 0647006D 0647008D 0647009D 0647010D 0647012D 0647014D 0647015D 0647016D 0647018D 0647019D 0647020D 0647021D 0647023D 0647024D 0647025D 0647026D 0647027D 0647028D 0647029D 0647031D 0647032D 0647034D 0647035D 0647036D 0647037D 06CON02507 7012010 07022013D 07032013D 7072014 0747491D 8152014 8182010 8272014 0840681D 0845166D 0845167D 0845171D 0845173D 0845176D…
Reason for recall
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
FDA-determined cause: Error in labeling
Action taken
Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to endorecall@stryker.com or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com. For questions regarding this recall call 408-754-2000.
Details
- Recall number
- Z-0623-2015
- Initiated
- November 17, 2014
- Posted by FDA
- December 12, 2014
- Terminated
- July 17, 2015
- Quantity
- 180,573 units total
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South…
- Recalling firm
- Stryker Endoscopy, San Jose, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0592-2015 Class II | PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide:…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0593-2015 Class II | PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 Laparoscopic Manual Instruments…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0594-2015 Class II | PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0595-2015 Class II | PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0596-2015 Class II | PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0597-2015 Class II | PKG, OP-BIOPSY FORCEPS, SPOON JAW, P/N 0250080007 Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0598-2015 Class II | PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0599-2015 Class II | PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0600-2015 Class II | PKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0601-2015 Class II | PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0602-2015 Class II | PKG, PORTIO ACORN SMALL ONLY, P/N 0250080139; Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0603-2015 Class II | PKG, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154; Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0604-2015 Class II | PKG, OBTURATOR, 5.5MM FOR HASSON CANNULA, P/N 0250080157; Laparoscopic Manual…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0605-2015 Class II | PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. Laparoscopic…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0606-2015 Class II | PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0607-2015 Class II | PKG, HASSON CANNULA, 5.5MM, AUTOMATIC VALVE, STOP COCK, P/N 0250080176. Laparoscopic…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0608-2015 Class II | PKG, MIXTER FORCEPS, P/N 0250080010. Laparoscopic Manual Instruments are intended for…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0609-2015 Class II | PKG, HOOK SCISSORS, P/N 0250080020. Laparoscopic Manual Instruments are intended for…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0610-2015 Class II | PKG, HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK, P/N 0250080179. Laparoscopic…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0611-2015 Class II | PKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0612-2015 Class II | PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080024. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0613-2015 Class II | PKG, METZENBAUM SCISSORS, CURVED, LONG, P/N 0250080025. Laparoscopic Manual Instruments…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0614-2015 Class II | PKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028. Laparoscopic Manual Instruments…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0615-2015 Class II | PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0616-2015 Class II | PKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0617-2015 Class II | PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. Laparoscopic Manual…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0618-2015 Class II | PKG, LUERLOCK, MALE, 6MM TUBING, P/N 0250080207. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0619-2015 Class II | PKG, LUERLOCK, FEMALE, 6MM TUBING, P/N 0250080208. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0620-2015 Class II | PKG, MARYLAND FORCEPS, CURVED, LEFT, P/N 0250080042. Laparoscopic Manual Instruments are…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |
| Z-0621-2015 Class II | PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080230. Laparoscopic Manual…The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070… | 11/17/2014Terminated |