Recall record at a glance
| Official record | Z-1591-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | ICU Medical, Inc. |
| Report date | May 13, 2015 |
| Recall initiation date | Apr 20, 2015 |
| Quantity | 900 units |
| Location | San Clemente, CA, United States |
Official product description
113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Why the product was recalled
ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
Distribution information
Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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