Device recall: Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM…
Class II FDA enforcement event 91324. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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, LP started this device recall on 2 Dec 2022. The firm address in the FDA record is in North Haven, CT. FDA put the recall in Class II. FDA event 91324 has 11 product records. The first FDA enforcement report date is 8 Mar 2023. The record gives the status Ongoing.
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 . openFDA export of .
Distribution
In the words of FDA.
US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia…
Recalling firm
Covidien, LP, 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
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1172-2023 | Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13 | 9606 | Class II | Ongoing | 8 Mar 2023 |
| Z-1173-2023 | Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11 (6)S913BX 5-0 NYLON 10 DS12 (7)S931BX 4-0 NYLON 10 DS12 | 12732 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1174-2023 | Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSOF* 1 BLK 100CM GCC90X12 CN-830-L MONOSOF* 1 BLK 150CM LP GS25 N-2781K MONOSOF* 5-0 BLK 45CM… | 54288 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1175-2023 | Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33 NOVAFIL 4-0 BLU 45CM SBE6 8886 4410-13 NOVAFIL 6-0… | 48492 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1176-2023 | Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36 GS835 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S1172… | 271800 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1177-2023 | Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA | 2070 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1178-2023 | Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK… | 87708 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1179-2023 | Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA | 8604 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1180-2023 | Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X SURGIPRO*II 7-0 60CM MV1758DA VP735X… | 322152 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1181-2023 | Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863035-51 TICRON… | 40152 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1182-2023 | Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK | 9606 | Class II | Ongoing | 8 Mar 2023 |
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 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 11Median of the firm: 2
- Events of the firm on the register
- 31
Other events of the firm
Official channels
- FDA enforcement report Z-1172-2023The 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.
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Cite this page
Recall Register. FDA enforcement event 91324. https://recallregister.com/fda/ii/91324/. Source: openFDA enforcement reports. Data through .
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 and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia…
- What quantity of product is in FDA event 91324?
- The event has 11 product records. The first record gives this quantity:
9606
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.