Z-2464-2018Class II

Prolene Suture Blue 18" 7-0 D/a Bv-1, Dc631

Name: Z-2464-2018 Prolene Suture Blue 18" 7-0 D/a Bv-1, Dc631
Creator: Ethicon, Inc.
Published: 2018-05-07
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2018-05-07 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631 on 2018-05-07. FDA classified it as Class II and gives the reason as "The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2464-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-07
Posted: 2018-07-17
Terminated: 2020-06-08
Recalling firm: Ethicon, Inc
Product: Prolene Suture Blue 18" 7-0 D/a Bv-1, Dc631
Product code: GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Reason for recall: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On May 24, 2018, the firm distributed Urgent: Medical Device Recall letters to affected U.S. customers. Customers were instructed to do the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. 4. Complete the Business Reply Form (BRF) confirming receipt of this notice and fax or email it to Stericycle at 1-888-473-8015 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this recall (removal). 5. Keep this notice visibly posted for awareness until all product subject to this recall (removal) has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. 6. Customers are required to return all unused D-Special PROLENE Polypropylene Suture & D-Special PRONOVA Poly (Hexafluoropropylene - VDF) Suture products that are in their inventory immediately. Only D-Special PROLENE Polypropylene Suture & D-Special PRONOVA Poly (Hexafluoropropylene - VDF) Suture product subject to this recall (removal) returned by September 21, 2018 will be eligible for credit reimbursement. Any product subject to this recall (removal) returned after September 21, 2018 will not be eligible for credit reimbursement. 7. To return product subject to this recall (removal), photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for
Quantity in commerce: 372
Distribution: Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.
Product codes and lots: LCJ948 MCQ529

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2464-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2448-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2449-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2450-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2451-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2452-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2453-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2454-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2455-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2456-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2457-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2458-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2459-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2460-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2461-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2462-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2463-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2464-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2465-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2466-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17

Product code GAW

K133356Class IIProlene Polypropylene Nonabsorbable SutureETHICON, Inc. / cleared 2013-12-06

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)