FDA Medical Device Recalls (openFDA)
Galt Medical Corporation: 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
- Recall number
- Z-2565-2018
- Recalling firm
- Galt Medical Corporation
- 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
- Status
- Terminated
- Initiated
- 2018-05-02
- Posted
- not on file
- Terminated
- 2020-07-20
- Reason
- 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.
- Root cause
- Other
- Action
- On approximately 05/01/2018 recall letters and customer response forms were mailed to all consignees.
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3000718472
- Firm city
- Garland
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28