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

Agency Publication Date: February 19, 2020

Affected Products

Product: 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.

1) Lot - A9H0927Y Expiration Date - 2024-07-31; 2) Lot - A9H1187Y Expiration Date - 2024-07-31; 3) Lot - A9J0383Y Expiration Date - 2024-08-31; 4) Lot - A9J0428Y Expiration Date - 2024-08-31

Product: 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.

1) Lot - A9H1189Y Expiration Date - 2024-07-31; 2) Lot - A9J0345Y Expiration Date - 2024-08-31

Product: 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.

1) Lot - A9J0014Y Expiration Date - 2024-08-31; 2) Lot - A9J0193Y Expiration Date - 2024-08-31

Product: 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.

Lot - A9K0004Y Expiration Date - 2024-09-30

Product: 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.

Lot - A9J0421Y Expiration Date - 2024-08-31

Product: 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.

Lot - A9J0053Y Expiration Date - 2024-08-31

Product: 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.

Lot - D7H0794X Expiration Date - 2022-08-31

Product: 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.

Lot - A9J0384Y Expiration Date - 2024-08-31

Product: 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.

Lot - D7G0387X Expiration Date - 2022-07-31

Product: 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.

Lot -D7H1126X Expiration Date - 2022-08-31

Product: 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.

Lot -D7H1092X Expiration Date - 2022-08-31

Product: 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.

Lot -D7H1214X Expiration Date - 2022-08-31

Product: 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.

Lot -A9H0847FY Expiration Date - 2024-07-31

Product: 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.

1) Lot -D7G2298X Expiration Date - 2022-07-31; 2) Lot - D7H0091X Expiration Date - 2022-08-31

Product: 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.

Lot - D7H0946X Expiration Date - 2022-08-31

Product: 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.

1) Lot - D7G2301X Expiration Date - 2022-07-31; 2) Lot - D7H0092X Expiration Date - 2022-08-31

Product: 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.

Lot - D7H0796X Expiration Date - 2022-08-31

Product: 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.

Lot - D7H0866X Expiration Date - 2022-08-31

Product: Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201

Lot - D7H0404X Expiration Date - 2022-08-31

Product: 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.

Lot - D7H1048X Expiration Date - 2022-08-31

Product: 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.

1) Lot - A9H1186Y Expiration Date - 2024-07-31; 2) Lot A9J0015Y Expiration Date - 2024-08-31

Lot Numbers:

A9J0015Y

Product: 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.

Lot - D7H0876X Expiration Date - 2022-08-31

Product: 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.

Lot - A9J0018Y Expiration Date - 2024-08-31

Product: 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.

Lot - A9J0075Y Expiration Date - 2024-08-31

Product: 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.

Lot - A9H1170Y Expiration Date - 2024-07-31

Product: 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.

Lot - A9H1065Y Expiration Date - 2024-07-31

Product: 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.

Lot - A9J0006Y Expiration Date - 2024-08-31

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84769

Status: Resolved

Manufacturer: Covidien LLC

Manufactured In: United States

Units Affected: 27 products (139,938 units total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.