REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly

FDA device recall Z-2006-2025 · posted 2025-06-23 · Open, Classified

Recall details

Recalling firm

Becton Dickinson Infusion Therapy Systems, Inc.

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Action taken

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.

Root cause

Component design/selection

Status

Open, Classified

Product code

FOZ

Quantity affected

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

Date initiated

2025-05-21

Date posted

2025-06-23

Location

Sandy, UT

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