The Recall Desk
ModerateFDA (Devices)·Z-0362-2022·Announced 2021-12-22

Bedside PICC CDS Convenience Kit Recalled for Expired Saline Component

Medline Industries is recalling the Bedside PICC CDS Convenience Kit because a saline injection bag component expired in April 2020 while the kit's expiration date was later. No injuries have been reported.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II medical device recall involving a quality-control defect where a component expired before the kit's expiration date. No illnesses or injuries reported; the hazard is precautionary rather than documented, placing this at Moderate per the rubric.

Plain-English summary

Medline Industries Inc is recalling the Bedside PICC CDS Convenience Kit due to a component expiration mismatch. The affected lot (19JBB553) was distributed nationwide in the United States.

The recalled kit contains a NaCl 250 mL Injection bag that expired in April 2020, while the overall kit's stated expiration date was September 30, 2021. This discrepancy means practitioners could potentially use an expired saline component during PICC catheter placement procedures.

No illnesses or injuries have been reported in connection with this recall. Affected healthcare facilities should stop using the recalled product and contact Medline Industries for replacement kits.

The recalled product

Product
Bedside PICC CDS Convenience Kit
Manufacturer
Medline Industries Inc
Hazard
  • expired-product
  • quality-control

Distribution

Distributed nationwide across the United States.