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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66238

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

Open FDA event record

Event summary

Timeline bucket
September 04, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corp.

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.

How coverage and grouping work

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

Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids.

Z-0099-2014
Recall number
Z-0099-2014
Initiated
September 04, 2013
Classification
Class II
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
3,200 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.

Code information

UR13C11089, UR13D16060

Distribution pattern

US Distribution including the states of OK, GA, CA, MN, TX and HI.