FDA Medical Device Recalls (openFDA)
COVIDIEN LLC: Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and to prevent the distention of the stomach.
- Recall number
- Z-0597-2019
- Recalling firm
- COVIDIEN LLC
- Product
- Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and to prevent the distention of the stomach.
- Status
- Terminated
- Initiated
- 2018-10-31
- Posted
- not on file
- Terminated
- 2020-05-26
- Reason
- This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the correct size is not readily available.
- Root cause
- Under Investigation by firm
- Action
- On October 31, 2018, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the incorrect packaging issue. Action Required: 1. INSPECT your inventory for the affected product code and lot number (listed on package) 2. SEGREGATE and QUARANTINE all on-hand product 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product youve quarantined or discarded. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall 5. CONTACT the appropriate Customer Service group to arrange for return and credit of any affected product: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other customers888-444-54401
- Quantity
- 1522
- Distribution
- Worldwide Distribution - US Nationwide and foreign distribution to Canada.
- Lot, serial or model codes
- 1812115564
- 510(k) numbers
- ["K810156"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28