Z-2096-2015Class II

Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use...

Name: Z-2096-2015 Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use...
Creator: Custom Healthcare Systems, Inc.
Published: 2014-11-05
License: https://open.fda.gov/license/

Manus Medical, LLC / initiated 2014-11-05 / Terminated / root cause: packaging

FDA source

Custom Healthcare Systems, Inc. began a recall of Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only on 2014-11-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2096-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-05
Posted: 2015-07-17
Terminated: 2016-01-12
Recalling firm: Manus Medical, LLC
Product: Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Product code: GCB Needle, Catheter
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: Custom Healthcare System sent an Urgent Product Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. PLEASE CHECK YOUR INVENTORY AND QUARANTINE ANY AFFECTED PRODUCT MATCHING THE DESCRIPTIONS ABOVE. Call 804 (421-5959) with regards to returning the affected products. Return Authorizations will be issued and product pickup and return will be scheduled.
Quantity in commerce: 3 Cs-Lot#92414 , 25 Cs-Lot#100214, 24 Cs-Lot#100914
Distribution: US Distribution to CT.
Product codes and lots: Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2096-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2096-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17

Product code GCB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)