The Recall Desk
HighFDA (Devices)·Z-1003-2017·Announced 2017-01-18

Corvida Medical Recalls Halo Closed System Transfer Devices Due to Malfunction

J&J Solutions, Inc. DBA Corvida Medical is recalling 5,520 Halo Closed System Transfer Devices because the needle does not retract. The devices were distributed in Maryland, Texas, and Wisconsin.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device malfunction (needle does not retract) which poses a risk of harm (needlestick injury), but no injuries or illnesses have been reported in the source text.

Plain-English summary

J&J Solutions, Inc. DBA Corvida Medical is recalling 5,520 units of the Halo Closed System Transfer Device, a closed syringe adaptor (REF CSA100). The recall is due to a product malfunction where the needle does not retract. The devices are sterile, prescription-only, and were packed and shipped in boxes of 60 units, with 4 boxes per shipping carton.

The affected units are from Lot 0610525, with a date of 2017-10-18. Distribution was limited to the United States, specifically to the states of Maryland, Texas, and Wisconsin. There was no foreign, military, or government distribution.

Healthcare providers and patients should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.
Affected units
5,520

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 0610525
  • 2017-10-18

Distribution

Distributed in 3 states: