1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12; 8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02; 9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88 10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;

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 #: 1) 18102478; 2) 18033450; 3) a) 18089973; b) 18031311; c) 18046318; d) 18082001; e) 18040777, 18061334; 4) S17342075; 5) P18015009; 6) S18051159, S18072306; 7) S18072307; 8) a) S18033049, S18064105, S18093202, S18096316; b) S18025037, S18032055, S18032100, S18032101, S18093199, S18096314; c) S18093200; d) S18032056, S18032102, S18052063, S18074161, S18093203, S18096318; e) S18064104, S18093201; f) S18096315; 9) S18018008; 10) a) G18012001, G18064125; b) S18017001
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:

1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12; 8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02; 9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88 10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;

Product Codes/Lot Numbers:

lot #: 1) 18102478; 2) 18033450; 3) a) 18089973; b) 18031311; c) 18046318; d) 18082001; e) 18040777, 18061334; 4) S17342075; 5) P18015009; 6) S18051159, S18072306; 7) S18072307; 8) a) S18033049, S18064105, S18093202, S18096316; b) S18025037, S18032055, S18032100, S18032101, S18093199, S18096314; c) S18093200; d) S18032056, S18032102, S18052063, S18074161, S18093203, S18096318; e) S18064104, S18093201; f) S18096315; 9) S18018008; 10) a) G18012001, G18064125; b) S18017001