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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86254

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

Open FDA event record

Event summary

Timeline bucket
August 03, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Riverpoint Medical, 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

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0010-2021
Recall number
Z-0010-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
7969

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20050709FX

Distribution pattern

US Nationwide distribution.

device · product 2 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0011-2021
Recall number
Z-0011-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
9820

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20051215FX

Distribution pattern

US Nationwide distribution.

device · product 3 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0012-2021
Recall number
Z-0012-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
8623

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20051216FX

Distribution pattern

US Nationwide distribution.

device · product 4 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0013-2021
Recall number
Z-0013-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
3109

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20051311X

Distribution pattern

US Nationwide distribution.

device · product 5 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0014-2021
Recall number
Z-0014-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
5479

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20051405FX

Distribution pattern

US Nationwide distribution.

device · product 6 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 20884521149370 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0015-2021
Recall number
Z-0015-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
5596

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20051406X

Distribution pattern

US Nationwide distribution.

device · product 7 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0016-2021
Recall number
Z-0016-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
3110

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20051814FX

Distribution pattern

US Nationwide distribution.

device · product 8 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-24, Product Number: SV9911G, UDI: 20884521149776 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0017-2021
Recall number
Z-0017-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1258

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20051815FX

Distribution pattern

US Nationwide distribution.

device · product 9 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper, Product Number: CV3110, UDI: 20884521150918 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0018-2021
Recall number
Z-0018-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
8598

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20051916X

Distribution pattern

US Nationwide distribution.

device · product 10 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0019-2021
Recall number
Z-0019-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1886

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20052017FX

Distribution pattern

US Nationwide distribution.

device · product 11 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-12, Cutting Product Number: CV486, UDI: 20884521150925 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0020-2021
Recall number
Z-0020-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1264

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20052102X

Distribution pattern

US Nationwide distribution.

device · product 12 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521151779 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0021-2021
Recall number
Z-0021-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1248

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20052701X

Distribution pattern

US Nationwide distribution.

device · product 13 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product Number: SV32, UDI: 20884521153117 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0022-2021
Recall number
Z-0022-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1270

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20052702FX

Distribution pattern

US Nationwide distribution.

device · product 14 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting, Product Number: SV4893, UDI: 20884521151717 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0023-2021
Recall number
Z-0023-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1267

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20052703FX

Distribution pattern

US Nationwide distribution.

device · product 15 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper, Product Number: CV3100, UDI: 20884521150901 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0024-2021
Recall number
Z-0024-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
6150

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20052720X

Distribution pattern

US Nationwide distribution.

device · product 16 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cutting, Product Number: SV496G, UDI: 20884521149691 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0025-2021
Recall number
Z-0025-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1267

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20052721FX

Distribution pattern

US Nationwide distribution.

device · product 17 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20 Taper, Product Number: CV416G, UDI: 20884521149363 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0026-2021
Recall number
Z-0026-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
3107

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20052815X

Distribution pattern

US Nationwide distribution.

device · product 18 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0027-2021
Recall number
Z-0027-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
3103

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20052816X

Distribution pattern

US Nationwide distribution.

device · product 19 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper, Product Number: CV1213, UDI: 20884521150758 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0028-2021
Recall number
Z-0028-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1248

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20052817X

Distribution pattern

US Nationwide distribution.

device · product 20 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884521184258 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0029-2021
Recall number
Z-0029-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
2499

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060116FX

Distribution pattern

US Nationwide distribution.

device · product 21 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product Number: SVP2251, UDI: 20884521177380 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0030-2021
Recall number
Z-0030-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1262

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060117FX

Distribution pattern

US Nationwide distribution.

device · product 22 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0031-2021
Recall number
Z-0031-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1264

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060118X

Distribution pattern

US Nationwide distribution.

device · product 23 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0032-2021
Recall number
Z-0032-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1268

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060119X

Distribution pattern

US Nationwide distribution.

device · product 24 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting Product Number: CV916, UDI: 20884521153032 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0033-2021
Recall number
Z-0033-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1276

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060120X

Distribution pattern

US Nationwide distribution.

device · product 25 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0034-2021
Recall number
Z-0034-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1811

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060201X

Distribution pattern

US Nationwide distribution.

device · product 26 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12 Cutting, Product Number: SV2295, UDI: 20884521151397 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0035-2021
Recall number
Z-0035-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1875

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060202FX

Distribution pattern

US Nationwide distribution.

device · product 27 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0036-2021
Recall number
Z-0036-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1272

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060203X

Distribution pattern

US Nationwide distribution.

device · product 28 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0037-2021
Recall number
Z-0037-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1256

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060204X

Distribution pattern

US Nationwide distribution.

device · product 29 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0038-2021
Recall number
Z-0038-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1260

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060205FX

Distribution pattern

US Nationwide distribution.

device · product 30 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0039-2021
Recall number
Z-0039-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1222

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060812X

Distribution pattern

US Nationwide distribution.

device · product 31 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0040-2021
Recall number
Z-0040-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1242

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060813FX

Distribution pattern

US Nationwide distribution.

device · product 32 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0041-2021
Recall number
Z-0041-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1236

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060814X

Distribution pattern

US Nationwide distribution.

device · product 33 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0042-2021
Recall number
Z-0042-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
3109

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060927X

Distribution pattern

US Nationwide distribution.

device · product 34 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151632 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0043-2021
Recall number
Z-0043-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1244

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060928X

Distribution pattern

US Nationwide distribution.

device · product 35 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0044-2021
Recall number
Z-0044-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1266

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060929FX

Distribution pattern

US Nationwide distribution.

device · product 36 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0045-2021
Recall number
Z-0045-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1253

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20060930X

Distribution pattern

US Nationwide distribution.

device · product 37 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0046-2021
Recall number
Z-0046-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
7496

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20061012FX

Distribution pattern

US Nationwide distribution.

device · product 38 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDI: 20884521150918 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0047-2021
Recall number
Z-0047-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
7982

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20061108X

Distribution pattern

US Nationwide distribution.

device · product 39 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0048-2021
Recall number
Z-0048-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
10457

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20061504FX

Distribution pattern

US Nationwide distribution.

device · product 40 of 40

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting SV2298, UDI: 20884521151021 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Z-0049-2021
Recall number
Z-0049-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
9214

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Code information

Lot Number: 20061715FX

Distribution pattern

US Nationwide distribution.