Z-1897-2011

Rusch Irrigation Tray w/Bulb Catalogue Number 68895 For irrigation according to institutional guidelines

Name: Z-1897-2011 Rusch Irrigation Tray w/Bulb Catalogue Number 68895 For irrigation according to institutional guidelines
Creator: Teleflex Medical
Published: 2011-02-24
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2011-02-24 / Terminated / root cause: sterility

FDA source

Teleflex Medical began a recall of Rusch Irrigation Tray w/Bulb Catalogue Number 68895 For irrigation according to institutional guidelines on 2011-02-24. The reason FDA records is "The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1897-2011
Status: Terminated
Initiated: 2011-02-24
Posted: 2011-04-05
Terminated: 2012-04-17
Recalling firm: Teleflex Medical
Product: Rusch Irrigation Tray w/Bulb Catalogue Number 68895 For irrigation according to institutional guidelines.
Product code: KMJ Lubricant, Patient
Reason for recall: The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination.
Root cause tag: sterility
FDA root cause: Other
Action: the firm,Teleflex Medical, sent two "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letters one dated February 24, 2011 and the other dated March 30, 2011 to all consignees and customers. The letters described the product, problem and actions to be taken. The consignees were instructed to communicate the recall to any of their customers who have received product included within the scope of the field corrective action via the customer letter. The customers were informed in the letter of concerns about potential bacterial contamination of the alcohol prep pads in the affected trays. If contaminated alcohol prep pads are used, there is a potential for infection to occur. The customers were instructed "that upon opening the affected trays for use, they should discard the prep pads as medical waste". The customers were also instructed to immediately discontinue use and quarantine any products with the product numbers and lot numbers listed; return the product, and complete and return the Recall Acknowledgement Form, even if they no affected product, via fax to 1-866-804-988, Attn: Customer Service (a customer service representative contact the customer with a Return Goods Authorization number and instructions for the return of the product to Teleflex Medical). If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: see line 1.
Distribution: Worldwide distribution: USA including states of: AL, AZ, CA, FL, GA, IL, MS, MI, MO, MS, NC, NJ, NH, NY, OH, PA, TX, UT, VA, Puerto Rica and the country of: Canada.
Product codes and lots: Catalogue Number 68895: Lot Numbers: 002516, 002520, 003512, 004513, 005510, 005528, 006510, 007513, 009512, 010507, 011506, 011511, 012514, 901524, 901545, 902506, 902519, 903508, 904511, 905502, 907516, 907528, 908518, 911512 and 912503.

Product code KMJ

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)