CLASS II ONGOING Device recall · Reported 7 Aug 2024 · FDA Enforcement Report
BD Insyte Autoguard BC, Shielded IV Catheter recalled
Becton Dickinson Infusion Therapy Systems is recalling BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, distributed in Illinois. The recall was initiated on 26 Jun 2024 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-2458-2024
- FDA event ID
- 94896
- Recalling firm
- Becton Dickinson Infusion Therapy Systems, Sandy, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jun 2024
- FDA classified
- 31 Jul 2024
- Reported
- 7 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 26 Jun 2024 | Recall initiated by company | |
| 31 Jul 2024 | Classified by FDA | +35 days |
| 7 Aug 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Where it was distributed
US: IL OUS: N/A0
Questions about this recall
Why was it recalled?
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Which lots are affected?
Lot # 4127714/ UDI-DI: 00382903825332
Where was it sold?
US: IL OUS: N/A0
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.
More recalls from Becton Dickinson Infusion Therapy Systems
All 15Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| 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 |