Recall Z-1300-2020
Covidien LLC · initiated December 18, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
Codes / lots: Lot - D7H0404X Expiration Date - 2022-08-31
Reason for recall
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
FDA-determined cause: Equipment maintenance
Action taken
On December 18, 2109, Medtronic issued Urgent Medical Device Recall and Return Form notices to customers via courier service. Customers were advised to take the following required actions: 1. Please immediately quarantine and discontinue use of the affected item code and lot listed within the notice. 2. Please return affected product as indicated within the notice. All unused products from the affected item codes and lots must be returned. 3. If you have distributed any of the Polysorb braided or Biosyn monofilament absorbable sutures listed on the recall notice, please promptly forward the information from the letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory.
Details
- Recall number
- Z-1300-2020
- Initiated
- December 18, 2019
- Posted by FDA
- February 19, 2020
- Terminated
- August 16, 2022
- Product code
- GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid
- Quantity
- 139,938 units total
- Distribution
- US Nationwide distribution.
- Recalling firm
- Covidien LLC, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1274-2020 Class II | Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 -…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1275-2020 Class II | Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1276-2020 Class II | Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1277-2020 Class II | Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1278-2020 Class II | Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1279-2020 Class II | Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1280-2020 Class II | Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1281-2020 Class II | Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1282-2020 Class II | Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1283-2020 Class II | Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1284-2020 Class II | Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1285-2020 Class II | Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1286-2020 Class II | Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1287-2020 Class II | Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1288-2020 Class II | Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1289-2020 Class II | Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1290-2020 Class II | Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1291-2020 Class II | Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1292-2020 Class II | Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1293-2020 Class II | Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1294-2020 Class II | Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1295-2020 Class II | Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1296-2020 Class II | Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1297-2020 Class II | Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1298-2020 Class II | Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |
| Z-1299-2020 Class II | Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage:…There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |