FDA Medical Device Recalls (openFDA)
Custom Healthcare Systems, Inc.: Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
- Recall number
- Z-2096-2015
- Recalling firm
- Custom Healthcare Systems, Inc.
- Product
- Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
- Status
- Terminated
- Initiated
- 2014-11-05
- Posted
- 2015-07-17
- Terminated
- 2016-01-12
- Reason
- 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
- 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
- 3 Cs-Lot#92414 , 25 Cs-Lot#100214, 24 Cs-Lot#100914
- Distribution
- US Distribution to CT.
- Lot, serial or model codes
- Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCB
- Firm FEI
- 1121091
- Firm city
- Richmond
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28