Recall record at a glance
| Official record | Z-2096-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Custom Healthcare Systems, Inc. |
| Report date | Jul 29, 2015 |
| Recall initiation date | Nov 5, 2014 |
| Quantity | 3 Cs-Lot#92414 , 25 Cs-Lot#100214, 24 Cs-Lot#100914 |
| Location | Richmond, VA, United States |
Official product description
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Why the product was recalled
An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior sealed STERILE KIT is correct and NO adverse issues affect that part of the item. The NON-STERILE OUTSIDE "PIGGYBACKED" PACKAGE mistakenly contains ITEM #8881579121 - Syringe prefilled, Saline Flush, 09% Sodium Chloride and is a NONSTERILE PRODUCT that CANNOT BE DROPPED INTO THE STERILE FIELD.
Distribution information
US Distribution to CT.
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: E-Mail.
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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.