Z-1223-2016Class II

Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the...

Name: Z-1223-2016 Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the...
Creator: Covidien LLC
Published: 2016-01-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-01-22 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients on 2016-01-22. FDA classified it as Class II and gives the reason as "Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1223-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-22
Posted: 2016-03-21
Terminated: 2017-06-20
Recalling firm: Medtronic, Inc.
Product: Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
Product code: EZL Catheter, Retention Type, Balloon
Reason for recall: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic/Covidien notfiied customersl via Federal Express on January 22, 2016,, The letter instructs customers to not use the Castile Soap Towelettes contained in the product kits listed on Attachment 1 and discard the affected towelettes. The Castile Soap packet included in these kits does not impact the integrity of the remaining products in the kit. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878. For questions regarding this recall call 203-492-5000.
Quantity in commerce: 95700
Distribution: US (nationwide) and to Canada.
Product codes and lots: Lot Codes: 511059464X 511851964X 513256664X 514650264X 515358464X 516050764X 516858564X 517457464X 520151064X 521058864X 522551264X 522958464X 523657064X 524357064X 525755764X 525755864X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1223-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1196-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1197-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1198-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1199-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1200-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1201-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1202-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1203-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1204-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1205-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1206-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1207-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1208-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1209-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1210-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1211-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1212-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1213-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1214-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1215-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1216-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1217-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1218-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1219-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1220-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1221-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1222-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1223-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1224-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1225-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1226-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1227-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1228-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21
Z-1229-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21

Product code EZL

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)