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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69604

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 09, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Becton Dickinson & Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples.

Z-0572-2015
Recall number
Z-0572-2015
Initiated
October 09, 2014
Classification
Class II
Status
Terminated
Quantity
US- 296,800 devices; OUS - 3,250,150 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD Insyte Autoguard may have potential damage along the body of the catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

BD Insyte Autoguard may have potential damage along the body of the catheter.

Code information

Distributed in USA REF#381433 20 G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65ml/min Lot numbers 4139786, Exp May-17; 4161662, Jun-17; 4164960, Jun-17; 4167812, Jun-17; 4174713, Jun-17; 4182668, Jun-17; 4182668, Jul-17 REF 381434 20 G x 1.16 in. BD Insyte Autoguard 1.1 x 30 mm 60 ml/min Lot numbers 4105724, Apr-17; 4107722, Apr-17; 4113707, Apr-17; 4113713, Apr-17 Distributed outside of USA REF# 381833 20G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65 ml/min Lot4143917, May -17 REF 3811834 20 G x 1.16 in. BD Insyte AUtoguard 1.1 x 30 mm 60ml/min Lot numbers 4119700, May-17; 4119730, May-17; 4129576, May-17; 4147742, May-17; 4107722, Apr-17

Distribution pattern

Worldwide Distribution - USA (naitonwide) and Internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste.