Reported Jun 21, 2023 · Ongoing
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
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?
- Tearaway Introducer Kit
- REF
KIT-010-12KIT-010-17KIT-900-16
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 00841268105195KIT-010-12/00841268105195/S23104607(2/05/2027), S22356870(1/11/2027) 2 00841268105249KIT-010-17/00841268105249/S23083725(2/05/2027), S22231321(9/08/2026), S22328872(1/18/2027) 3 KIT-900-16/S22308637(1/04/2027) - Amount recalled
- 490
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Galt Medical Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.