PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration...
FDA Device Recall #Z-0386-2019 — Class II — September 26, 2018
Recall Summary
| Recall Number | Z-0386-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 26, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson & Company |
| Location | Franklin Lakes, NJ |
| Product Type | Devices |
| Quantity | 566,737 total |
Product Description
PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module directions for Use for complete loading and operating instructions. Notes: The set should be changed according to the facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
Reason for Recall
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MT, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Guam. The products were distributed to the following foreign countries: Canada, United Arab Emirates and Saudi Arabia.
Lot / Code Information
Batch numbers: 15086977 15095397 15095915 15096391 15096849 15096850 15106576 15106951 15115143 15115716 15115717 16017458 16025336 16025977 16036016 16045460 16045487 16055501 16065137 16065138 16065714 16066549 16067125 16067126 16067127 16067128 16077716 16085262 16085367 15026445 15026291 15026195 15026194 15025581 14116628 14115971 14106583 14106255 14105065 16085368 16087180 16095824 16095862 16096932 16096933 16105618 16107358 16107359 16115132 16125018 16126788 16127223 17015091 17016118 17016119 17017235 17025472 17026261 17026967 17036238 17036239 17056659 17057076 17057077 17065203 17065204 17065249 17066157 15016971 15016044 15015678 14125371 14116627 14056317 14045325 14036825 14036236 14035806 14096716 14096388 14095389 14086964 14085752 14085232 14077092 14076307 14075202 14066846 14066080 14035268 14026691 14026388 14025707 14016290 14016373 14015841 13125080 13116634 13115751 13115436 17085229 17085260 17087278 17096726 17096817 17096818 17096980 17116510 17117476 17117526 17125486 17125487 17125488 17125559 17126893 17126907 18015151 18015152 18015153 18016346 18026103 18026223 18026224
Other Recalls from Becton Dickinson & Company
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1496-2026 | Class II | 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. ... | Jan 27, 2026 |
| Z-0504-2026 | Class II | BD Luer Tip Caps; Catalog Number(s) or Model N... | Oct 14, 2025 |
| Z-0736-2024 | Class II | PosiFlush Prefilled Saline Syringe with General... | Nov 16, 2023 |
| Z-0349-2024 | Class II | BD Alaris Pump infusion sets (Product Name, Cat... | Oct 11, 2023 |
| Z-0351-2024 | Class II | BD Extension Sets (Product Name, Catalog #) ... | Oct 11, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.