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.
FDA Recall Z-2458-2024 · Posted 2024-07-31
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Recalling FirmBecton Dickinson Infusion Therapy Systems, Inc.
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2024-06-26
Product Quantity26,400 units
Reason for Recall
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Firm Action
On June 26, 2024, Becton Dickinson Infusion Therapy Systems Inc. issued a "Urgent: Medical Device Product Recall" Notification to affected consignees via: mail. BD ask consignees to take the following actions:
1. Ensure the contents of this Product Recall communication are read and understood by those within your organization.
2. Immediately review your inventory for Catalog Number 382533, Lot number 4127714. Destroy all unused product subject to the recall following your institution s process for destruction.
3. If affected device was previously used on a patient without incident, no further action is necessary. If the device is currently in use and issue has not been observed, continue to use as normal.
4. Notify any and all entities of this recall to whom the affected product may have been transferred.
5. Complete the attached Customer Response Form and return to your distributor, whether or not you have any of the impacted material.
Root Cause
Process control
Distribution Pattern
US: IL OUS: N/A0
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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