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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67733

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 11, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teleflex Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation.

Z-1291-2014
Recall number
Z-1291-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
Total 32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The products are being recalled because they did not meet minimum needle attachment strength requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Code: 1154654, Lot number: 02K0801212

Distribution pattern

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

device · product 2 of 6

Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation.

Z-1292-2014
Recall number
Z-1292-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
Total 32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The products are being recalled because they did not meet minimum needle attachment strength requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Code: 0100019-507, Lot number: 02F1301128; Product Code: 6-511, Lot number: 02M0800561; Product Code: 6-559, Lot number: 02A0800005; Product Code: 69-403, Lot number: 02H0802530; Product Code: 7-5008M4, Lot number: 02C0900466; Product Code: 7-518, Lot number: 02E1302561; Product Code: 7-565, Lot number: 02B1100185; Product Code: 7-655A, Lot numbers: 02C0901963 & 02M0800836; Product Code: 7-740, Lot number: 02L1000536; Product Code: 833-114, Lot numbers: 02A1202112, 02C0903374 & 02D1202794; Product Code: 02F0902697, 02K1100404, 02L1202369 & 02M0802509; Product Code: E13-6351, Lot number: 02F0902446; Product Code: E13-6354, Lot number: 02F0902439; Product Code: E13-6399, Lot number: 02F0902436; Product Code: E6-545, Lot number: 02F0902443; Product Code: E7-4578, ot number: 02D0901672; Product Code: H5300, Lot number: 1450153E13; Product Code: RN6-5106M5, Lot number: 02F1003837; Product Code: RN7-536M5, Lot number: 02A0801205; Product Code: TEV100, Lot number: 02G1101500; Product Code: V-2599, Lot number: 02F0802055; Product Code: X-5424, Lot number: 02B0900765; Product Code: X6-692W, Lot number: 02C0803135; Product Code: X7-655M6A, Lot number: 02A0900806, 02A0902742, 02C0900446 & 02H1003233 and Product Code: XF7-7011, Lot numbers: 02A0901594.

Distribution pattern

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

device · product 3 of 6

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.

Z-1293-2014
Recall number
Z-1293-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
Total 32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The products are being recalled because they did not meet minimum needle attachment strength requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

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

device · product 4 of 6

Sutures, Absorbable, Synthetic, Polyglycolic Acid, 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.

Z-1294-2014
Recall number
Z-1294-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
Total 32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The products are being recalled because they did not meet minimum needle attachment strength requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Code: BON100, Lot numbers: 02H1302839, 02J1101705, 02D1101137, and 02F1103013.

Distribution pattern

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

device · product 5 of 6

Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or Ushaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Z-1295-2014
Recall number
Z-1295-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
Total 32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The products are being recalled because they did not meet minimum needle attachment strength requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Code: X-4981M4, Lot number: 02J0800451

Distribution pattern

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

device · product 6 of 6

Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

Z-1296-2014
Recall number
Z-1296-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
Total 32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The products are being recalled because they did not meet minimum needle attachment strength requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Code: X-6371M5, Lot numbers: 02E0801603

Distribution pattern

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