Device recall: Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in…

Class II FDA enforcement event 84769. Recall start date: 18 Dec 2019. Status in the FDA record: Terminated. Termination date: 16 Aug 2022.

Reason for recall, in the words of FDA

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Covidien LLC started this device recall on 18 Dec 2019. The firm address in the FDA record is in North Haven, CT. FDA put the recall in Class II. FDA event 84769 has 27 product records. The first FDA enforcement report date is 26 Feb 2020. The record gives the status Terminated, with the termination date 16 Aug 2022.

FDA enforcement report The 27 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide distribution.

Recalling firm

Covidien LLC, North Haven, CT.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

27 product records in the event.

FDA event 84769: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1274-2020	Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1275-2020	Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1276-2020	Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1277-2020	Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1278-2020	Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1279-2020	Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1280-2020	Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1281-2020	Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1282-2020	Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1283-2020	Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1284-2020	Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1285-2020	Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1286-2020	Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1287-2020	Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1288-2020	Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1289-2020	Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1290-2020	Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1291-2020	Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1292-2020	Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1293-2020	Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1294-2020	Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1295-2020	Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1296-2020	Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1297-2020	Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1298-2020	Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1299-2020	Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	139,938 units total	Class II	Terminated	26 Feb 2020
Z-1300-2020	Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201	139,938 units total	Class II	Terminated	26 Feb 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 27Median of the firm: 1
Events of the firm on the register: 77

Other events of the firm

Other FDA enforcement events of Covidien LLC
Initiated	Product (first record)	Type	Class	Records
13 May 2026	EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOF	Device	Class II	1
23 Apr 2026	Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042	Device	Class II	3
23 Apr 2026	Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidi	Device	Class II	1
15 Apr 2026	COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intende	Device	Class II	1
30 Jan 2026	HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 M	Device	Class II	1
25 Apr 2024	EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only	Device	Class II	1
2 Jun 2023	Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-US	Device	Class II	1
22 May 2023	Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS	Device	Class II	1
23 Nov 2022	COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1	Device	Class II	1
19 Aug 2022	Puritan Bennett 560 Ventilator, PB560, CFN 4096600	Device	Class II	1

Covidien LLC: all 77 events

Official channels

FDA enforcement report Z-1274-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 84769. https://recallregister.com/fda/ii/84769/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide distribution.
What quantity of product is in FDA event 84769?: The event has 27 product records. The first record gives this quantity: 139,938 units total
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.