Z-1557-2014Class II

Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston...

Name: Z-1557-2014 Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston...
Creator: Teleflex Medical
Published: 2014-03-11
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-03-11 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated... on 2014-03-11. FDA classified it as Class II and gives the reason as "Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1557-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Posted: 2014-05-07
Terminated: 2017-08-14
Recalling firm: Teleflex Medical
Product: Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.
Product code: GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Reason for recall: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.
Quantity in commerce: 32,271 ea.
Distribution: Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
Product codes and lots: Product Code 833-123 - Lot 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, 02K1102309, Product Code 833-124 - Lot 02A1200503, 02B1101450, 02C0903400, 02D0900010, 02D0900103, 02D1003285, 02D1003286 02F1302321, 02G1000045, 02G1300348, 02G1301122, 02H1100494, 02L0803407, 02L1100009, 02M1002289, 02M1101933, 02F1302322, Product Code 833-213 - Lot 02H1100687, Product Code D-5007K - Lot 02B1002310, 02C1103731, 02F1100069, 02H1102294, Product Code D-5007M4A - Lot 02M0902844, Product Code D-5007M4K - Lot 02C1002252, 02F1100124, Product Code D-7016M4K - Lot 02G1301749, Product Code D-7070K - Lot 02A1103450, 02B1002276, Product Code D-7070M4K - Lot 02C1103707, 02F1301100, 02G1100876, 02G1301739, 02F1101036, 02J1301343, 02K0900010, Product Code D-7076M1K - Lot 02H1103237, Product Code D-7375K - Lot 02A1201015, Product Code D-793M4K - Lot 02L1002488, Product Code ED-6072 - Lot 02C1002218, 02E1002342, 02J0902517, Product Code ED-6276 - Lot 02F0902457, Product Code ED-6896 - Lot 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, 02G1301755, Product Code ED-852 - Lot 02G1002594, Product Code ED-863 - Lot 02B0902976, 02D0902457, 02M0901348.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1557-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1555-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06
Z-1556-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06
Z-1557-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06
Z-1558-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06
Z-1559-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06
Z-1560-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06
Z-1561-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06

Product code GAQ

K930738Class IISurgical Sutures, Pgl, Gut, Deklene, Opthamend EtcDeknatel, Inc. / cleared 1994-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)