Z-2611-2018Class II
32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing...
Abbott Medical / initiated 2017-07-31 / Terminated / root cause: labeling and UDI
ICU Medical, Inc. began a recall of 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile... on . FDA classified it as Class II and gives the reason as "Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-2611-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Abbott Medical
- Product
- 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
- Product code
- FMG Stopcock, I.V. Set
- Reason for recall
- Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
- Root cause tag
- labeling and UDI
- FDA root cause
- Labeling mix-ups
- Action
- The firm, ICUmedical, notified their customers of the recall on about 07/31/2017 via"URGENT: Medical Device Recall Notification letter". Instructions included to inspect inventory on hand for affected devices, remove and return any affected devices, and complete and return the Recall Response Form to ICU Medical RecallCoordinator; email:[email protected]; including labeling "Incorrect labeling" in subject or FAX: (801) 264-1755. Instructions also included to notify customers of the recall if devices were further distributed. Questions can be directed to ICU Customer Service Monday through Friday, 7 AM CST - 4:30 PM CT at 877-946-7747, option 9 or e-mail at [email protected]
- Quantity in commerce
- 160,016 units total
- Distribution
- Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
- Product codes and lots
- Item Number 061-C6028, Lot Number 3414382
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2606-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2607-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2608-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2609-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2610-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2611-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2612-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2613-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2614-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2615-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2616-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2617-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2618-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2619-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2620-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2621-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2622-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2623-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2624-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2625-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2626-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2627-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2628-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2629-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2630-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2631-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2632-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2633-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2634-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2635-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2636-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2637-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2638-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2639-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2640-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2641-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2642-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2643-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2644-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2645-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2646-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2647-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2648-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2649-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2650-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2651-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2652-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2653-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2654-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2655-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2656-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2657-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2658-2018 | Class II | Terminated | Voluntary: Firm initiated |
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