CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
CK000495A Poly Midline Catheter Single-Lumen recalled
Bard Access Systems is recalling CK000495A Poly Midline Catheter Single-Lumen, distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2656-2026
- FDA event ID
- 99096
- Recalling firm
- Bard Access Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 May 2026
- FDA classified
- 2 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 21 May 2026 | Recall initiated by company | |
| 2 Jul 2026 | Classified by FDA | +42 days |
| 8 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Product as listed by the FDA
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling.
Where it was distributed
Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Which lots are affected?
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 Lot Number: REKV1588 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKX0938 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKY1965
Where was it sold?
Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 99096More recalls from Bard Access Systems
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |
| Device | CLASS I | Power-Trialysis Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | 5605150 Power-Trialysis Short-Term Straight Dialysis recalled | Bard Access Systems | Other | Nationwide |
| Device | CLASS II | 1174108 PowerPICC Catheter Single-Lumen recalled by Bard Access Systems | Bard Access Systems | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,217| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | System (RED 62 Reperfusion Catheter) recalled by Penumbra | Penumbra | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |