Recall Z-2558-2018
Galt Medical Corporation · initiated May 2, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;
Codes / lots: Lot #: 1) a) S18015025; b) S18015026, c) S18015027; d) S18046198; 2) a) G17356364; 3) a) S18016057, S18106396, b) S18080265 4) a) S18032092, S18032093, S18032094; b) S18046163;
Reason for recall
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
FDA-determined cause: Other
Action taken
On approximately 05/01/2018 recall letters and customer response forms were mailed to all consignees.
Details
- Recall number
- Z-2558-2018
- Initiated
- May 2, 2018
- Terminated
- July 20, 2020
- Product code
- DYB – Introducer, Catheter
- Quantity
- 3160
- Distribution
- U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea
- Recalling firm
- Galt Medical Corporation, Garland, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2559-2018 Class II | 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO…The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | 05/02/2018Terminated |
| Z-2560-2018 Class II | 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b)…The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | 05/02/2018Terminated |
| Z-2561-2018 Class II | 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10…The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | 05/02/2018Terminated |
| Z-2562-2018 Class II | Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d)…The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | 05/02/2018Terminated |
| Z-2563-2018 Class II | Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | 05/02/2018Terminated |
| Z-2564-2018 Class II | TVS LPA, Catalog #: DIL-059-00The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | 05/02/2018Terminated |
| Z-2565-2018 Class II | Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d)…The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | 05/02/2018Terminated |