Z-2004-2025Class II
REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min...
Becton Dickinson Infusion Therapy Systems Inc. / initiated 2025-05-21 / Open, Classified / root cause: design
Becton Dickinson Infusion Therapy Systems, Inc. began a recall of REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly on . FDA classified it as Class II and gives the reason as "Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2004-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Becton Dickinson Infusion Therapy Systems Inc.
- Product
- REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
- Product code
- FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Reason for recall
- Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- Root cause tag
- design
- FDA root cause
- Component design/selection
- Action
- On May 21, 2025, Becton Dickinson Infusion Therapy (BD) issued a "Urgent: Medical Device Recall" Notification to affected consignees FedEx and E-Mail. BD asked consignees to take the following actions: 1. Immediately review your inventory for product listed in the above table. Cease use and destroy any unused affected devices. 2. For devices that have deployed and are currently in use or if an impacted device was previously used, no additional follow-up activities are required for patients that have completed therapy. 3. Share and post this Product Recall letter within your facility network and forward to any customers you may have distributed the product to ensure awareness. Ensure the contents of this Product Recall are read and understood by those within your organization. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification.
- Quantity in commerce
- 50 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.
- Product codes and lots
- Lot# 4208538/UDI: 00382903818112
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1999-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2000-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2001-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2002-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2003-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2004-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2005-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2006-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2007-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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