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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Medline Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Vascular CDS Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
Same hazard · expired product
See all →- ModerateExpressaire Disposable Tourniquet Cuff Recalled for Incorrect Expiration Date
FDA (Devices) · 2026-10-07
- ModerateFDA Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateFDA Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- HighMedline Shoulder CDS Kits Recalled Due to Expired Irrigation Component
FDA (Devices) · 2021-08-18
- ModerateMedline Total Knee Surgical Kit Recalled for Expired Irrigation Component
FDA (Devices) · 2021-08-18
- HighMedline Medical Convenience Kits with Plastic Syringes Recalled for Quality Defects
FDA (Devices) · 2024-09-18
- HighMedline Arthroscopy Kit Recalled for Expired Irrigation Component
FDA (Devices) · 2021-08-18
- SevereMedline Convenience Kits Recalled Due to Syringe Quality Issues
FDA (Devices) · 2024-09-18
- HighMedline Knee Arthroscopy Kit Recalled for Expired Irrigation Component
FDA (Devices) · 2021-08-18