CLASS II Device recall · Reported 2 Apr 2014 · FDA Enforcement Report

Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile recalled

Teleflex Medical is recalling Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, distributed nationwide in the US. The recall was initiated on 11 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 833-123, Lot numbers: 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, & 02K1102309; Product Code: 833-124, Lot numbers: 02A1200503, 02B1101450 & 02C0903400; Product Code: 02D0900010, 02D0900103, 02D1003285, 02D1003286 & 02F1302321; Product Code: 02G1000045, 02G1300348, 02G1301122, 02H1100494, & 02L0803407; Product Code: 02L1100009, 02M1002289, 02M1101933 & 02F1302322; 833-213, Lot number: 02H1100687; Product Code: D-5007K, Lot numbers: 02B1002310, 02C1103731, 02F1100069 & 02H1102294; Product Code: D-5007M4A, Lot number: 02M0902844; Product Code: D-5007M4K, Lot numbers: 02C1002252, & 02F1100124; Product Code: D-7016M4K, Lot number: 02G1301749; Product Code: D-7070K, Lot numbers: 02A1103450 & 02B1002276: Product Code: D-7070M4K, Lot numbers: 02C1103707, 02F1301100, 02G1100876 & 02G1301739; Product Code: D-7076M1K, Lot number: 02H1103237; Product Code: D-7076M4K, Lot numbers: 02F1101036, 02J1301343, and 02K0900010: Product Code: D-7375K, Lot number: 02A1201015; Product Code: D-793M4K, Lot number: 02L1002488; Product Code: ED-6072, Lot numbers: 02C1002218, 02E1002342 & 02J0902517; Product Code: ED-6276, Lot number: 02F0902457; Product Code: ED-6896, Lot numbers: 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, & 02G1301755; Product Code: ED-853, Lot numbers: 02G1002594, 02B0902976, 02D0902457 & 02M0901348 and Product Code: EP4049N, Lot number: 02A1003137.

Quantity recalledTotal 32,271 ea.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1293-2014
FDA event ID: 67733
Recalling firm: Teleflex Medical, Research Triangle Park, NC
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2014
FDA classified: 25 Mar 2014
Reported: 2 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

11 Mar 2014	Recall initiated by company
25 Mar 2014	Classified by FDA	+14 days
2 Apr 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Product as listed by the FDA

Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.

Where it was distributed

Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

Nationwide

Questions about this recall

Why was it recalled?

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Which lots are affected?

Product Code: 833-123, Lot numbers: 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, & 02K1102309; Product Code: 833-124, Lot numbers: 02A1200503, 02B1101450 & 02C0903400; Product Code: 02D0900010, 02D0900103, 02D1003285, 02D1003286 & 02F1302321; Product Code: 02G1000045, 02G1300348, 02G1301122, 02H1100494, & 02L0803407; Product Code: 02L1100009, 02M1002289, 02M1101933 & 02F1302322; 833-213, Lot number: 02H1100687; Product Code: D-5007K, Lot numbers: 02B1002310, 02C1103731, 02F1100069 & 02H1102294; Product Code: D-5007M4A, Lot number: 02M0902844; Product Code: D-5007M4K, Lot numbers: 02C1002252, & 02F1100124; Product Code: D-7016M4K, Lot number: 02G1301749; Product Code: D-7070K, Lot numbers: 02A1103450 & 02B1002276: Product Code: D-7070M4K, Lot numbers: 02C1103707, 02F1301100, 02G1100876 & 02G1301739; Product Code: D-7076M1K, Lot number: 02H1103237; Product Code: D-7076M4K, Lot numbers: 02F1101036, 02J1301343, and 02K0900010: Product Code: D-7375K, Lot number: 02A1201015; Product Code: D-793M4K, Lot number: 02L1002488; Product Code: ED-6072, Lot numbers: 02C1002218, 02E1002342 & 02J0902517; Product Code: ED-6276, Lot number: 02F0902457; Product Code: ED-6896, Lot numbers: 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, & 02G1301755; Product Code: ED-853, Lot numbers: 02G1002594, 02B0902976, 02D0902457 & 02M0901348 and Product Code: EP4049N, Lot number: 02A1003137.

Where was it sold?

Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 67733

This product is part of a recall event; the main page for the event is Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile recalled.

Reported	Class	Recall	Company	Reason	Where
2 Apr 2014	CLASS II	Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile recalled	Teleflex Medical	Other	Nationwide
2 Apr 2014	CLASS II	Sutures, Non-absorbable, Steel, Monofilament recalled	Teleflex Medical	Foreign Material	Nationwide
2 Apr 2014	CLASS II	Suture, Non-absorbable, Synthetic, Polyamide, Sterile recalled	Teleflex Medical	Other	Nationwide
2 Apr 2014	CLASS II	Sutures, Non-absorbable, Silk, Sterile recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
2 Apr 2014	CLASS II	Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile recalled	Teleflex Medical	Other	Nationwide

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