Recall Z-2565-2018
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
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
Codes / lots: Lot #: a) 18024880, 18043086, 18066833, 18073282; b) 18039555, 18059249, 18074835; c) 17363134; d) 17352818, 18051601; e) 18019228, 18047509; f) 18023833; g) 17356436, 18018694, 18018695, 18040074; h) 18061579; i) 18015027; j) 18019038, 18029067, 18033068, 18075816, 18075817, 18075818; k) 17363816, 18023834, 18026040, 18026072, 18033073, 18033079, 18054248; l) 18005018, 18012032, 18012034, 18012035, 18012036, 18019037, 18026953, 18089355, 18096357, 18096358, 18103359; m) 18047202; n) 18054349
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-2565-2018
- Initiated
- May 2, 2018
- Terminated
- July 20, 2020
- Product code
- DYB – Introducer, Catheter
- Quantity
- 23777
- 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-2558-2018 Class II | 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a)…The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | 05/02/2018Terminated |
| 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 |