Reported Aug 8, 2018 · Terminated
1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #:…
Galt Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Galt Medical Corporation · 2220 Merritt Dr · Garland, TX · 75041-6137
Is this the product you have?
- 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;
- Lot codes and dates
20 of 20 products
Products covered by this recall # Product as published 1 18102478 2 18033450 3 a) 18089973 4 18031311 5 18046318 6 18082001 7 18040777, 18061334 8 S17342075 9 P18015009 10 S18051159, S18072306 11 S18072307 12 a) S18033049, S18064105, S18093202, S18096316 13 S18025037, S18032055, S18032100, S18032101, S18093199, S18096314 14 S18093200 15 S18032056, S18032102, S18052063, S18074161, S18093203, S18096318 16 S18064104, S18093201 17 S18096315 18 S18018008 19 a) G18012001, G18064125 20 S18017001 - Amount recalled
- 9050
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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