Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91069

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

Open FDA event record

Event summary

Timeline bucket
October 20, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ROi CPS 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

40 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 40

regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit

Z-0283-2023
Recall number
Z-0283-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
42 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717110392, Lot Number 91590, exp 01/09/2024

Distribution pattern

LA, MO, NC, FL

device · product 2 of 40

regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit

Z-0284-2023
Recall number
Z-0284-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
204 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717103288, Lot Number 91622, exp 2/22/2024

Distribution pattern

LA, MO, NC, FL

device · product 3 of 40

regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit

Z-0285-2023
Recall number
Z-0285-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
326 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717104605, Lot Numbers: 91014, exp 05/01/2023; 92342, exp 07/01/2023; 91672, exp 07/01/2023

Distribution pattern

LA, MO, NC, FL

device · product 4 of 40

regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit

Z-0286-2023
Recall number
Z-0286-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
18 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717109723, Lot Numbers: 91417, exp 2/2/2024

Distribution pattern

LA, MO, NC, FL

device · product 5 of 40

regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit

Z-0287-2023
Recall number
Z-0287-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
190 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717109914, Lot Numbers: 91329, exp 11/27/2022

Distribution pattern

LA, MO, NC, FL

device · product 6 of 40

regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit

Z-0288-2023
Recall number
Z-0288-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
160 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717115397, Lot Numbers: 92346, exp 2/14/2024

Distribution pattern

LA, MO, NC, FL

device · product 7 of 40

regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit

Z-0289-2023
Recall number
Z-0289-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
164 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717108849, Lot Numbers: 91281, exp 5/28/2023; 91103, exp 10/11/2023

Distribution pattern

LA, MO, NC, FL

device · product 8 of 40

regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit

Z-0290-2023
Recall number
Z-0290-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
76 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717107897, Lot Numbers: 92222, exp 4/21/2024

Distribution pattern

LA, MO, NC, FL

device · product 9 of 40

regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit

Z-0291-2023
Recall number
Z-0291-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
69 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717112501, Lot Numbers: 91643, exp 7/1/2023; 91242, exp 8/12/2023

Distribution pattern

LA, MO, NC, FL

device · product 10 of 40

regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit

Z-0292-2023
Recall number
Z-0292-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
38 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10174717108863, Lot Numbers: 91577, exp 2/7/2023; 91382, exp 12/7/2023

Distribution pattern

LA, MO, NC, FL

device · product 11 of 40

regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

Z-0293-2023
Recall number
Z-0293-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
200 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717079958, Lot Numbers: 92037, exp 1/31/2023; 91205, exp 6/30/2023

Distribution pattern

LA, MO, NC, FL

device · product 12 of 40

regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit

Z-0294-2023
Recall number
Z-0294-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
170 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717107392, Lot Numbers: 91107, exp 1/8/2024; 91879, exp 3/18/2024

Distribution pattern

LA, MO, NC, FL

device · product 13 of 40

regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit

Z-0295-2023
Recall number
Z-0295-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
258 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717110767, Lot Numbers: 92051, exp 7/1/2023; 91671, exp 1/29/2024

Distribution pattern

LA, MO, NC, FL

device · product 14 of 40

regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit

Z-0296-2023
Recall number
Z-0296-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
38 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717110682, Lot Numbers: 92200, exp 4/14/2024

Distribution pattern

LA, MO, NC, FL

device · product 15 of 40

regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit

Z-0297-2023
Recall number
Z-0297-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
20 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717101314, Lot Numbers: 91760, exp 11/8/2023

Distribution pattern

LA, MO, NC, FL

device · product 16 of 40

regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit

Z-0298-2023
Recall number
Z-0298-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
30 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717110811, Lot Numbers: 92354, exp 1/31/2023

Distribution pattern

LA, MO, NC, FL

device · product 17 of 40

regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit

Z-0299-2023
Recall number
Z-0299-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
146 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10174717110880, Lot Numbers: 91522, exp 2/7/2023; 91118, exp 10/18/2023; 91705, exp 12/30/2023; 92034, exp 1/26/2024

Distribution pattern

LA, MO, NC, FL

device · product 18 of 40

regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit

Z-0300-2023
Recall number
Z-0300-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
32 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717101611, Lot Numbers: 92674, exp 9/30/2023; 93459, exp 9/30/2023,

Distribution pattern

LA, MO, NC, FL

device · product 19 of 40

regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit

Z-0301-2023
Recall number
Z-0301-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
8 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717109297, Lot Numbers: 92327, exp 4/26/2024

Distribution pattern

LA, MO, NC, FL

device · product 20 of 40

regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit

Z-0302-2023
Recall number
Z-0302-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
21 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717114062, Lot Numbers: 91584, exp 9/23/2023

Distribution pattern

LA, MO, NC, FL

device · product 21 of 40

¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit

Z-0303-2023
Recall number
Z-0303-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
108 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717114895, Lot Numbers: 92534, exp 11/13/2022; 93366, exp 2/28/2023

Distribution pattern

LA, MO, NC, FL

device · product 22 of 40

regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit

Z-0304-2023
Recall number
Z-0304-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
125 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717113911, Lot Numbers: 91560, exp 12/7/2023; 92467, exp 2/14/2024

Distribution pattern

LA, MO, NC, FL

device · product 23 of 40

¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit

Z-0305-2023
Recall number
Z-0305-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
456 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717113478, Lot Numbers: 91163, exp 1/10/2024; 91669, exp 2/25/2024; 92537, exp 5/15/2024

Distribution pattern

LA, MO, NC, FL

device · product 24 of 40

¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit

Z-0306-2023
Recall number
Z-0306-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
258 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717113485, Lot Numbers: 92643, exp 5/24/2024; 93393, exp 8/18/2024; 93669, exp 9/26/2024

Distribution pattern

LA, MO, NC, FL

device · product 25 of 40

regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit

Z-0307-2023
Recall number
Z-0307-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
243 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717114789, Lot Numbers: 92274, exp 5/2/2024

Distribution pattern

LA, MO, NC, FL

device · product 26 of 40

¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit

Z-0308-2023
Recall number
Z-0308-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
213 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717103301, Lot Numbers: 91005, exp 2/27/2023; 91543, exp 2/16/2024

Distribution pattern

LA, MO, NC, FL

device · product 27 of 40

regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit

Z-0309-2023
Recall number
Z-0309-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
177 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717114536, Lot Numbers: 92275, exp 4/22/2024

Distribution pattern

LA, MO, NC, FL

device · product 28 of 40

regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit

Z-0310-2023
Recall number
Z-0310-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
228 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717113119, Lot Numbers: 90987, exp 12/28/2023; 91804, exp 3/18/2024; 92715, exp 6/6/2024

Distribution pattern

LA, MO, NC, FL

device · product 29 of 40

regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit

Z-0311-2023
Recall number
Z-0311-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
790 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717111306, Lot Numbers: 91012, exp 9/28/2023; 91752, exp 1/29/2024; 92497, exp 2/14/2024

Distribution pattern

LA, MO, NC, FL

device · product 30 of 40

regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit

Z-0312-2023
Recall number
Z-0312-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
248 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717113331, Lot Numbers: 91174, exp 10/18/2023; 91908, exp 2/2/2024; 92566, exp 2/14/2024

Distribution pattern

LA, MO, NC, FL

device · product 31 of 40

regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit

Z-0313-2023
Recall number
Z-0313-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
188 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717109457, Lot Numbers: 92239, exp 11/27/2023; 91440, exp 12/7/2023

Distribution pattern

LA, MO, NC, FL

device · product 32 of 40

regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit

Z-0314-2023
Recall number
Z-0314-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
268 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717104322, Lot Numbers: 91465, exp 2/7/2024; 92444, exp 5/5/2024

Distribution pattern

LA, MO, NC, FL

device · product 33 of 40

regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit

Z-0315-2023
Recall number
Z-0315-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
738 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717104643, Lot Numbers: 91479, exp 2/10/2024

Distribution pattern

LA, MO, NC, FL

device · product 34 of 40

regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit

Z-0316-2023
Recall number
Z-0316-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
780 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717114635, Lot Numbers: 92164, exp 4/7/2024

Distribution pattern

LA, MO, NC, FL

device · product 35 of 40

regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit

Z-0317-2023
Recall number
Z-0317-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
166 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717104742, Lot Numbers: 91265, exp 1/20/2024; 92541, exp 5/17/2024

Distribution pattern

LA, MO, NC, FL

device · product 36 of 40

regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit

Z-0318-2023
Recall number
Z-0318-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
28 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717105121, Lot Numbers: 91778, exp 3/8/2024

Distribution pattern

LA, MO, NC, FL

device · product 37 of 40

regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit

Z-0319-2023
Recall number
Z-0319-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
54 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717105763, Lot Numbers: 91403, exp 2/4/2024; 92161, exp 4/12/2024

Distribution pattern

LA, MO, NC, FL

device · product 38 of 40

regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit

Z-0320-2023
Recall number
Z-0320-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
24 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717109426, Lot Numbers: 90993, exp 10/11/2023; 91722, exp 1/12/2024

Distribution pattern

LA, MO, NC, FL

device · product 39 of 40

regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit

Z-0321-2023
Recall number
Z-0321-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
302 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10194717113713, Lot Numbers: 91240, exp 8/3/2023; 92740, exp 2/14/2024

Distribution pattern

LA, MO, NC, FL

device · product 40 of 40

regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit

Z-0322-2023
Recall number
Z-0322-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
90 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information

UDI/DI 10174717114185, Lot Numbers: 92206, exp 1/26/2024

Distribution pattern

LA, MO, NC, FL