Recall Z-2284-2021— Cardinal Health

Name: FDA recall Z-2284-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-04

Class I · Ongoing

Class I FDA medical device recall by Cardinal Health, initiated 2021-08-04. It names one FDA 510(k) clearance: K032438. Product: Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.. Reason: Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe..

Recalling firm: Cardinal Health
Classification: Class I
Status: Ongoing
Initiated: 2021-08-04
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K032438 — MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGETyco Healthcare·cleared 2004-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Reason for recall

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

Data sourced from openFDA. This site is unofficial and independent of the FDA.