FDA (Devices) recall action 84769

Covidien LLC recalled 27 products on 2020-02-26

The FDA (Devices) publishes a recall like this one as 27 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 27 pages.

Products: 27
Announced: 2020-02-26
Critical: 0
Units: 3,778,326

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 27

ModerateFDA (Devices)··2020-02-26
FDA Recalls Polysorb Sutures Due to Potential Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
SevereFDA (Devices)··2020-02-26
Recall of Polysorb Sutures Due to Potential Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact sterility.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
FDA Recalls Polysorb Suture Due to Packaging Integrity Concerns
The FDA is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that could impact sterility.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
FDA Recalls Polysorb Sutures Due to Potential Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
Polysorb Suture Recalled for Potential Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
Polysorb Suture Recall Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact sterility.
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.
Category
Distribution
0 states
SevereFDA (Devices)··2020-02-26
FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise sterility.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise sterility.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture 13-0 due to potential packaging integrity issues that may impact sterility.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
FDA Recalls Polysorb Sutures Due to Packaging Integrity Concerns
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise the sterility barrier.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise sterility.
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.
Category
Distribution
0 states
SevereFDA (Devices)··2020-02-26
Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
FDA Recalls Polysorb Sutures Due to Packaging Integrity Concerns
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise sterility.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
FDA Recalls Polysorb Braided Absorbable Sutures Due to Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise the sterility barrier.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
Recall of Polysorb Sutures Due to Potential Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
Biosyn Monofilament Absorbable Suture Recalled for Packaging Integrity Issues
FDA is recalling Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23 due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Product
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
Polysorb Suture Recall Due to Packaging Integrity Issues
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact sterility.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
Polysorb Suture Recalled for Potential Packaging Integrity Issues
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2020-02-26
FDA Recalls Polysorb Sutures Due to Potential Sterility Barrier Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise the sterility barrier.
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.
Category
Distribution
0 states