FDA Medical Device Recalls (openFDA)
Medline Industries Inc: ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
- Recall number
- Z-2724-2020
- Recalling firm
- Medline Industries Inc
- Product
- ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
- Status
- Open, Classified
- Initiated
- 2020-06-30
- Posted
- not on file
- Terminated
- not on file
- Reason
- There are reports of the suction catheter coming apart from the device assembly during use.
- Root cause
- Process control
- Action
- Customer letter dated 06/29/2020 was issued to consignees. Consignees are asked to check their inventory for impacted product and destroy affected product. Consignees are asked to complete and return a destruction form listing quantity of affected product destroyed or indicate no product was on hand. Additionally, if product has been further distributed, consignees are asked to notify those customers who may be impacted.
- Quantity
- 2440 units
- Distribution
- US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.
- Lot, serial or model codes
- Model: DYNCPTP14, Lot #6919020016:
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSY
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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