RecallRadar

FDA Device recall Z-0948-2014

Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Rep…

On 2014-02-19 the FDA classified a Class II recall of Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Rep… by Ecolab, citing certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0948-2014
ClassificationClass II
Statusterminated
Initiated2013-07-02
Published2014-02-19
Last updated2026-09-13 11:53 UTC
CompanyEcolab
DistributionUS

Product

Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois

Reason

Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

Identifiers

code_infoLot Numbers: D111571, D120421, D123471, D83111, DA90721, and DA90961

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0948-2014%22

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