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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73121

34 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Covidien LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

34 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 34

Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients

Z-1196-2016
Recall number
Z-1196-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
33312

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 525157164X 524356164X 522957364X 522355664X 521058064X 520856764X 520159364X

Distribution pattern

US (nationwide) and to Canada.

device · product 2 of 34

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

Z-1197-2016
Recall number
Z-1197-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
16500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 522959464X 525757064X

Distribution pattern

US (nationwide) and to Canada.

device · product 3 of 34

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

Z-1198-2016
Recall number
Z-1198-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 523657764X

Distribution pattern

US (nationwide) and to Canada.

device · product 4 of 34

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

Z-1199-2016
Recall number
Z-1199-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
74300 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 518151164X 519450564X 520850264X 521250764X 522951064X 525150364X 525251064X

Distribution pattern

US (nationwide) and to Canada.

device · product 5 of 34

Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are used to clean the genital area for male and female patients

Z-1200-2016
Recall number
Z-1200-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
118400 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 518151164X 519450564X 520850264X 521250764X 522951064X 525150364X 525251064X

Distribution pattern

US (nationwide) and to Canada.

device · product 6 of 34

Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area for male and female patients

Z-1201-2016
Recall number
Z-1201-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
18000 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 512590564X 516087864X 517488664X 518889264X 520288264x 521689164X

Distribution pattern

US (nationwide) and to Canada.

device · product 7 of 34

Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used to clean the genital area for male and female patients

Z-1202-2016
Recall number
Z-1202-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
207000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 513287864X 514688164X 518187764X 520288464X 523087364X

Distribution pattern

US (nationwide) and to Canada.

device · product 8 of 34

Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patients

Z-1203-2016
Recall number
Z-1203-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
10,000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 510450164X 524350264X

Distribution pattern

US (nationwide) and to Canada.

device · product 9 of 34

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

Z-1204-2016
Recall number
Z-1204-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
20400

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 513256364X 514555864X 516050164X 516852964X 517456764X

Distribution pattern

US (nationwide) and to Canada.

device · product 10 of 34

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

Z-1205-2016
Recall number
Z-1205-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
3000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 520858064X

Distribution pattern

US (nationwide) and to Canada.

device · product 11 of 34

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

Z-1206-2016
Recall number
Z-1206-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
1800

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 516050264X 522957864X

Distribution pattern

US (nationwide) and to Canada.

device · product 12 of 34

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

Z-1207-2016
Recall number
Z-1207-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
4200

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 515358964X 517457664X

Distribution pattern

US (nationwide) and to Canada.

device · product 13 of 34

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

Z-1208-2016
Recall number
Z-1208-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
71430

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 511053864X 514553364X 515354264X 516054064X 516853764X 518154764X 518854864X 520155564X 520853164X 522550264X 522950064X 524353064X 525450164X 525752564X

Distribution pattern

US (nationwide) and to Canada.

device · product 14 of 34

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

Z-1209-2016
Recall number
Z-1209-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
83400

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 511053864X 514553364X 515354264X 516054064X 516853764X 518154764X 518854864X 520155564X 520853164X 522550264X 522950064X 524353064X 525450164X 525752564X

Distribution pattern

US (nationwide) and to Canada.

device · product 15 of 34

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

Z-1210-2016
Recall number
Z-1210-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
7200

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 520858164X 525756164X

Distribution pattern

US (nationwide) and to Canada.

device · product 16 of 34

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

Z-1211-2016
Recall number
Z-1211-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
3600

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 509759364X 513256864X 516050864X

Distribution pattern

US (nationwide) and to Canada.

device · product 17 of 34

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

Z-1212-2016
Recall number
Z-1212-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
31200

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 513256264X 515358164X 517457064X 520550064X 520857464X 521058564X 522958064X 525153264X

Distribution pattern

US (nationwide) and to Canada.

device · product 18 of 34

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

Z-1213-2016
Recall number
Z-1213-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
7200

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 515358664X 518150564X 522551064X

Distribution pattern

US (nationwide) and to Canada.

device · product 19 of 34

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

Z-1214-2016
Recall number
Z-1214-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
600

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 515359164X

Distribution pattern

US (nationwide) and to Canada.

device · product 20 of 34

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

Z-1215-2016
Recall number
Z-1215-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
11400

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 511752564X 516054164X 520853264X 525450264X

Distribution pattern

US (nationwide) and to Canada.

device · product 21 of 34

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

Z-1216-2016
Recall number
Z-1216-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
7200

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 520857564X 522553864X 522958164X 523656864X 525153364X 525755664X

Distribution pattern

US (nationwide) and to Canada.

device · product 22 of 34

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

Z-1217-2016
Recall number
Z-1217-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
600

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 516050964X

Distribution pattern

US (nationwide) and to Canada.

device · product 23 of 34

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 clean the genital area for male and female patients

Z-1218-2016
Recall number
Z-1218-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
300

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 524356364X

Distribution pattern

US (nationwide) and to Canada.

device · product 24 of 34

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

Z-1219-2016
Recall number
Z-1219-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
4500

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 516853264X 517457164X 525153464X

Distribution pattern

US (nationwide) and to Canada.

device · product 25 of 34

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

Z-1220-2016
Recall number
Z-1220-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
16500

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 511059164X 511851264X 515358364X 516853364X 517457264X 520150864X 522958264X 525153564X

Distribution pattern

US (nationwide) and to Canada.

device · product 26 of 34

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

Z-1221-2016
Recall number
Z-1221-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
1320

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 518150464X

Distribution pattern

US (nationwide) and to Canada.

device · product 27 of 34

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

Z-1222-2016
Recall number
Z-1222-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
5940

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 512551264X 515359064X 523657564X

Distribution pattern

US (nationwide) and to Canada.

device · product 28 of 34

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

Z-1223-2016
Recall number
Z-1223-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
95700

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 511059464X 511851964X 513256664X 514650264X 515358464X 516050764X 516858564X 517457464X 520151064X 521058864X 522551264X 522958464X 523657064X 524357064X 525755764X 525755864X

Distribution pattern

US (nationwide) and to Canada.

device · product 29 of 34

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

Z-1224-2016
Recall number
Z-1224-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
13060

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 511059764X 516853664X 521750064X 525350464X

Distribution pattern

US (nationwide) and to Canada.

device · product 30 of 34

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

Z-1225-2016
Recall number
Z-1225-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
25080

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 511851364X 512550364X 515357964X 518150364X 520150964X 523656964X 524356864X

Distribution pattern

US (nationwide) and to Canada.

device · product 31 of 34

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

Z-1226-2016
Recall number
Z-1226-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
1950

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 512551364X 516051164X 521750164X

Distribution pattern

US (nationwide) and to Canada.

device · product 32 of 34

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

Z-1227-2016
Recall number
Z-1227-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
9200

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 512550564X 513256764X 515358564X 522551364X

Distribution pattern

US (nationwide) and to Canada.

device · product 33 of 34

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

Z-1228-2016
Recall number
Z-1228-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
1980

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 509054664X 512550964X 525154064X

Distribution pattern

US (nationwide) and to Canada.

device · product 34 of 34

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

Z-1229-2016
Recall number
Z-1229-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
3280

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Code information

Lot Codes: 512550464X 525153664X

Distribution pattern

US (nationwide) and to Canada.