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

Class I - Dangerous

🏥 Medical Devices Recalled: May 2, 2018 Galt Medical Other Medical Devices

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Galt Medical Corporation
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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