Z-0771-2017Class II

RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile...

Name: Z-0771-2017 RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile...
Creator: Teleflex Medical
Published: 2016-11-22
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-11-22 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization on 2016-11-22. FDA classified it as Class II and gives the reason as "Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0771-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2016-12-16
Terminated: 2017-11-24
Recalling firm: Teleflex Medical
Product: RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Product code: KOD Catheter, Urological
Reason for recall: Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated November 22, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers with affected stock, immediately discontinue use and quarantine any affected products. To return product, customers were advised to complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Customers with no affected stock should also complete the enclosed Recall Acknowledgment Form to confirm receipt of the letter. Customers with questions should contact Customer Service at 1-866-246-6990.
Quantity in commerce: 102,843 units
Distribution: Nationwide Distribution to CA, CO, FL, GA, IL, KS, KY, MA, MO, MS, NC, NJ, NY, OH, OK, OR, PA and TX.
Product codes and lots: Product Code: 10096080, Lot number: 74F1501853 (8 FR); Product Code: 10096120, Lot numbers: 74E1602795, 74F1503201, 74G1600723 & 74J1500576 (12 FR); Product Code: 10096140, Lot numbers: 74A1600023, 74A1601105, 74A1602234, 74D1602007, 74E1602235, 74E1602796, 74F1501855, 74G1600486, 74H1500530 & 74L1500363 (14 FR); Product Code: 10096100, Lot numbers: 74A1600799, 74A1600800, 74A1602236, 74A1603122, 74D1600231, 74D1600923, 74D1601540, 74D1602136, 74E1600845, 74E1601768, 74E1602237, 74F1501857, 74F1501962, 74F1601966, 74F1601988, 74H1500534, 74H1500978, 74J1501157, 74K1502306, 74L1500364, 74L1501303, 74L1501938, 74M1500227 and 74M1501087 (10 FR) and Product Code: 10096160, Lot numbers: 74A1600024, 4A1600801, 74A1601106, 74A1603123, 74D1601541, 74E1600846, 74E1602797, 74G1600724, 74H1500979, 74J1501158, 74K1501837, 74L1501202 &74L1501939 (16 FR).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0771-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0771-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-16

Product code KOD

K010420Class IIRusch Mmg/o'neil CatheterRusch, Inc. / cleared 2001-05-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)