Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100

FDA Device Recall #Z-1581-2022 — Class II — July 22, 2022

Recall Summary

Recall Number Z-1581-2022
Classification Class II — Moderate risk
Date Initiated July 22, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Baxter Healthcare Corporation
Location Deerfield, IL
Product Type Devices
Quantity 8500 units

Product Description

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100

Reason for Recall

There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

Distribution Pattern

Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.

Lot / Code Information

REF H938677100 , UDI 00085412479873, ALL LOTS

Other Recalls from Baxter Healthcare Corporation

Recall # Classification Product Date
Z-1573-2026 Class II Brand Name: Welch Allyn, Inc. Product Name: We... Feb 18, 2026
Z-1368-2026 Class II Brand Name: Spectrum IQ Product Name: Infusion... Jan 13, 2026
Z-1121-2026 Class II SIGMA Spectrum Infusion Pump, Model/Catalog Num... Nov 28, 2025
Z-0847-2026 Class II Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalo... Oct 28, 2025
Z-0233-2026 Class II Oral Probe (Product code 02893-000), accessory ... Sep 17, 2025

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.