Medline Industries, Lp: Catheter Introducer Kit
Recall Summary Merit Medical is recalling their 16F Dual-Valved Splittable Sheath Introducer, a dialysis catheter device, because the sheath may not split properly during use. If the sheath fails to split as designed, patients could experience bleeding, blood clots, or damage to blood vessels that would prevent future access for dialysis treatment. This recall affects dialysis catheter devices distributed by Merit Medical.
- Recalling firm
- Medline Industries, LP
- Product
- Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
- Reason
- The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b1764621-4af2-419c-be4a-7a5bd80fde1d