Recall Z-0858-2013
Codman & Shurtleff, Inc. · initiated January 11, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Codes / lots: All unexpired lots
Reason for recall
Sterility of device may be compromised due to lack of package integrity
FDA-determined cause: Component design/selection
Action taken
Codman sent an Urgent Voluntary Product Recall Notification letter dated January 11, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to check all inventory to determine if they have any affected product, use the included instructions to report inventory status, return and obtain replacement product. Customers were instructed to contact your local Codman Representative or Stericycle at 1-866-201-9077. For questions regarding this recall call 508-880-8100.
Details
- Recall number
- Z-0858-2013
- Initiated
- January 11, 2013
- Posted by FDA
- February 20, 2013
- Terminated
- August 10, 2015
- Product code
- DQY – Catheter, Percutaneous
- Quantity
- 46 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0842-2013 Class II | NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the…Sterility of device may be compromised due to lack of packaging integrity | 01/11/2013Terminated |
| Z-0843-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0844-2013 Class II | NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0845-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0846-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0847-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0848-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0849-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0850-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0851-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0852-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0853-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0854-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0855-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0856-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0857-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0859-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0860-2013 Class II | NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0861-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0862-2013 Class II | NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0863-2013 Class II | NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0864-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0865-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |