Device recall: Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and…
Class II FDA enforcement event 73121. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Covidien LLC started this device recall on 22 Jan 2016. The firm address in the FDA record is in North Haven, CT. FDA put the recall in Class II. FDA event 73121 has 34 product records. The first FDA enforcement report date is 30 Mar 2016. The record gives the status Terminated, with the termination date 20 Jun 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US (nationwide) and to Canada.
Recalling firm
Covidien LLC, North Haven, CT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
34 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1196-2016 | Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients | 33312 | Class II | Terminated | 30 Mar 2016 |
| Z-1197-2016 | Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are used to clean the genital area for male and female patients | 16500 units | Class II | Terminated | 30 Mar 2016 |
| Z-1198-2016 | Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towelettes are used to clean the genital area for male and female patients | N/A | Class II | Terminated | 30 Mar 2016 |
| Z-1199-2016 | Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male and female patients | 74300 kits | Class II | Terminated | 30 Mar 2016 |
| Z-1200-2016 | Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are used to clean the genital area for male and female patients | 118400 kits | Class II | Terminated | 30 Mar 2016 |
| Z-1201-2016 | Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area for male and female patients | 18000 kits | Class II | Terminated | 30 Mar 2016 |
| Z-1202-2016 | Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used to clean the genital area for male and female patients | 207000 | Class II | Terminated | 30 Mar 2016 |
| Z-1203-2016 | Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patients | 10,000 | Class II | Terminated | 30 Mar 2016 |
| Z-1204-2016 | Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female patients | 20400 | Class II | Terminated | 30 Mar 2016 |
| Z-1205-2016 | Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap towelettes are used to clean the genital area for male and female patients | 3000 | Class II | Terminated | 30 Mar 2016 |
| Z-1206-2016 | Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients | 1800 | Class II | Terminated | 30 Mar 2016 |
| Z-1207-2016 | Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD Castile soap towelettes are used to clean the genital area for male and female patients | 4200 | Class II | Terminated | 30 Mar 2016 |
| Z-1208-2016 | Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male and female patients | 71430 | Class II | Terminated | 30 Mar 2016 |
| Z-1209-2016 | Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients | 83400 | Class II | Terminated | 30 Mar 2016 |
| Z-1210-2016 | Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male and female patients | 7200 | Class II | Terminated | 30 Mar 2016 |
| Z-1211-2016 | Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female patients | 3600 | Class II | Terminated | 30 Mar 2016 |
| Z-1212-2016 | Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients | 31200 | Class II | Terminated | 30 Mar 2016 |
| Z-1213-2016 | Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes are used to clean the genital area for male and female patients | 7200 | Class II | Terminated | 30 Mar 2016 |
| Z-1214-2016 | Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital area for male and female patients | 600 | Class II | Terminated | 30 Mar 2016 |
| Z-1215-2016 | Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for male and female patients | 11400 | Class II | Terminated | 30 Mar 2016 |
| Z-1216-2016 | Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male and female patients | 7200 | Class II | Terminated | 30 Mar 2016 |
| Z-1217-2016 | Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for male and female patients | 600 | Class II | Terminated | 30 Mar 2016 |
| Z-1218-2016 | Covidien Dover 18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STANDARD TRAY COMPONENTS INCLUDING HAND SANITIZER AND SKIN BARR Item Code: P4P18XCSDK Castile soap towelettes are used to… | 300 | Class II | Terminated | 30 Mar 2016 |
| Z-1219-2016 | Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients | 4500 | Class II | Terminated | 30 Mar 2016 |
| Z-1220-2016 | Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: PP14SD Castile soap towelettes are used to clean the genital area for male and female patients | 16500 | Class II | Terminated | 30 Mar 2016 |
| Z-1221-2016 | Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD Castile soap towelettes are used to clean the genital area for male and female patients | 1320 | Class II | Terminated | 30 Mar 2016 |
| Z-1222-2016 | Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Castile soap towelettes are used to clean the genital area for male and female patients | 5940 | Class II | Terminated | 30 Mar 2016 |
| Z-1223-2016 | 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 | 95700 | Class II | Terminated | 30 Mar 2016 |
| Z-1224-2016 | Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and female patients | 13060 | Class II | Terminated | 30 Mar 2016 |
| Z-1225-2016 | Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients | 25080 | Class II | Terminated | 30 Mar 2016 |
| Z-1226-2016 | Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients | 1950 | Class II | Terminated | 30 Mar 2016 |
| Z-1227-2016 | Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patients | 9200 | Class II | Terminated | 30 Mar 2016 |
| Z-1228-2016 | Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for male and female patients | 1980 | Class II | Terminated | 30 Mar 2016 |
| Z-1229-2016 | Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients | 3280 | Class II | Terminated | 30 Mar 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 34Median of the firm: 1
- Events of the firm on the register
- 77
Other events of the firm
Official channels
- FDA enforcement report Z-1196-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 73121. https://recallregister.com/fda/ii/73121/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US (nationwide) and to Canada.
- What quantity of product is in FDA event 73121?
- The event has 34 product records. The first record gives this quantity:
33312
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.