Cardinal Health: Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components: a) Jobri Circumcision Strap, Small, 2 x 8 inch, component part number 086-0001; b) Jobri Circumcision Strap, Large, 2 x 10 inch, component part number 086-0002; The restraint is used to secure an infant during a circumcision procedure. Product Usage: The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant during a circumcision procedure.

Recall number

Z-0926-2012

Recalling firm

Cardinal Health

Product

Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components: a) Jobri Circumcision Strap, Small, 2 x 8 inch, component part number 086-0001; b) Jobri Circumcision Strap, Large, 2 x 10 inch, component part number 086-0002; The restraint is used to secure an infant during a circumcision procedure. Product Usage: The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant during a circumcision procedure.

Status

Terminated

Initiated

2011-12-23

Posted

2012-01-27

Terminated

2016-08-01

Reason

The Presource kits were assembled with a Jobri Infant Restraint Strap which does not have the appropriate 510(k) pre-market clearance.

Root cause

No Marketing Application

Action

Cardinal Health issued an URGENT: PRODUCT RECALL letter dated December 23, 2011 to the affected hospital consignees via UPS next day air. The letter identified the product, problem, and actions to be taken. Enclosed with the letter were recall labels, instructing the customer not to use the affected component upon opening the kit, to affix recall label to the front side of each affected Presource kit and shipping carton currently in their inventory. The customers were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules labeled. For component credit/replacement the consignees were instructed to contact the folowing: Hospitals - Presource Sales Operations at 800-766-0706; Federal Government facilities - Government Customer Service at 800-444-1166; and Distributors - Distributor Management Group at 800-635-6021. For any questions, require additional labels or desire special assistance relating to this recall contact Cardinal Health Quality Systems, 800-292-9332.

Quantity

15,369 kits in total

Distribution

Nationwide Distribution (USA) including the states of: Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Maryland, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Virginia, Washington and West Virginia.

Lot, serial or model codes

all recent lots of the following kit catalog numbers 02-0114C, 02-0336, 02-0619, 02-0790A, 02-1502B, 02-1880, 02-2064, 02-2843A, 02-3022A, 02-3867I, 02-3867J, 02-4716C, 02-7483, 02A0790A, 02B0790, 10-0023C, 10-0059A, 10-0078, 10-0079B, 10-0089, 10-1077B, 10-2637C, 10-3050C, NI10-0007B, NI10-0020H, NI10-0039, NI10-0073B, NI10-0083, NI10-5406, NI10-7799D, NI10-8184A and NI12-1714

510(k) numbers

not on file

PMA numbers

not on file

Product code

LRO

Firm FEI

3001236905

Firm city

Park

Firm state

IL

Firm country

not on file

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

Copy