Z-1256-2016Class II
30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter...
Abbott Medical / initiated 2016-02-25 / Terminated
ICU Medical, Inc. began a recall of 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices... on . FDA classified it as Class II and gives the reason as "ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1256-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Abbott Medical
- Product
- 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal of fluids.
- Product code
- ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Reason for recall
- ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
- FDA root cause
- Under Investigation by firm
- Action
- A customer notification letter dated 2/25/16 was sent to all customers who purchased the IV Administration Sets with ChemoLock Port to inform them that ICU Medical has identified an issue with a connection in an isolated number of I.V. Infusion administration sets that incorporate the ChemoLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak. Customers are informed of the actions to be taken. Customers are instructed to return and complete the recall response form to ICU Medical via Fax (801) 264-1755 or by email: [email protected]. Customers with questions or require assistance relating to the recall are instructed to contact Customer Service Monday through Friday between the hours of 8:30AM-4:00PM Pacific Time, (866) 829-9025 and select option 8, or email at [email protected].
- Quantity in commerce
- 50 units
- Distribution
- US: NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO Non-US: DE, AE, AT, PL, HU, SE, IL, JP, JO, SA,
- Product codes and lots
- 2938262
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1254-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1255-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1256-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1257-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1258-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1259-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1260-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1261-2016 | Class II | Terminated | Voluntary: Firm initiated |
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