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PDS recallZ-2147-2024 · Ethicon, Inc. · initiated May 10, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

FDA root cause category: Under Investigation by firm

What the company is doing

Erhicon issued Urgent: Medical Device Recall (Removal) letter on May 10, 2024 to US Distributors, primary and secondary consignees via UPS second day. Ethicon Johnson & Johnson affiliates in EMEA, LATAM, APAC and Canada will be contacting all their impacted primary and secondary consignees and/or end customers. Letter states reason for recall, health risk and action to take: 1. Determine whether you have inventory of the lots listed in Attachment 1. If so, you may " Option 1: Remove the first package of suture from a complete box, i. Quarantine and return it for credit. You may use the remaining 35 sutures in accordance with the IFU. (See Figure 2 below for location of first package) OR ii. Examine the first package of a complete box prior to use. Quarantine and return this unit if a packaging defect is identified. (See Figure 2 below for location of first package). If no defect is found, the product and remaining 35 sutures in the box may be used accordance with the IFU. OR "Option 2: Quarantine all product in scope and return all inventory for credit. Please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email to Sedgwick at 800-901-0335 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused sutures with holes in the primary packaging subject to this recall that are in inventory immediately. To receive credit for items returned, customers must return product no

Recall details

Recall number
Z-2147-2024
Status
Open, Classified
Initiated by the company
May 10, 2024
Posted by the FDA
Jun 14, 2024
Recalling firm
Ethicon, Inc.
Quantity
45828 units
Product code
NEW
FDA submissions
K212380, K061037
Distribution
Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.

Product description

PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H

Code information (models, lots, serial numbers)

GTIN: 10705031047976 10705031048027 10705031048119 PRODUCT CODE PRODUCT LOTS PDP304H TLMJLZ PDP316H UAMKDC PDP341H UBMCZA

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

49 devices cleared under K212380, K061037 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94643).

Sources and updates

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