Recall Z-1826-2022
Cook Incorporated · initiated August 16, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
Codes / lots: TSMB-35-145 (GPN G27041) UDI-DI 00827002270411, Lot 14797970, Expiration Date 16-06-2027
Reason for recall
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
FDA-determined cause: Under Investigation by firm
Action taken
On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
Details
- Recall number
- Z-1826-2022
- Initiated
- August 16, 2022
- Posted by FDA
- September 28, 2022
- Product code
- DQX – Wire, Guide, Catheter
- Quantity
- 43 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recalling firm
- Cook Incorporated, Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1824-2022 Class II | Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1825-2022 Class II | Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip)…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1827-2022 Class II | Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1828-2022 Class II | Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1829-2022 Class II | Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1830-2022 Class II | Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1831-2022 Class II | Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1832-2022 Class II | Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1833-2022 Class II | Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1834-2022 Class II | Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1835-2022 Class II | Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1836-2022 Class II | Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1837-2022 Class II | Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1838-2022 Class II | Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1839-2022 Class II | Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1840-2022 Class II | Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1841-2022 Class II | Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1842-2022 Class II | Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1843-2022 Class II | Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1844-2022 Class II | Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1845-2022 Class II | Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1846-2022 Class II | Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1847-2022 Class II | Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |