FDA Medical Device Recalls (openFDA)
Teleflex Medical: RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
- Recall number
- Z-1685-2019
- Recalling firm
- Teleflex Medical
- Product
- RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
- Status
- Terminated
- Initiated
- 2019-04-01
- Posted
- not on file
- Terminated
- 2025-06-03
- Reason
- The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- Root cause
- Process control
- Action
- The firm initiated the recall by letter on 04/01/2019. The letter stated reason for the recall and requested the return of the recalled units. Distributors were directed to collect the recalled units from their customers, consolidate them, and complete and return the acknowledgement form. The recalled units will be returned.
- Quantity
- 4312 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 14161, 14171, 14201, 14211, 14231, 14261, 14301, 14311, 14361, 14431, 14481, 14491, 15041, 15051, 15081, 15091, 15121, 15131, 15161, 15171, 15201, 15221, 15241, 15261, 15371, 15411, 15421, 15501, 16031, 16071, 16111, 16151, 16161, 16181, 16201, 16221, 16241, 16251, 16271, 16281, 16291, 16301, 16351, 16361, 16371, 16381, 16391, 16401, 16421, 16441, 16461, 16471, 16481, 17061, 17071, 17161, 17191, 17211, 17221, 17251, 17271, 17291, 17301, 17311, 17381, 17391, 17411, 17471, 17481, 17511, 18021, 18081, 18091, 18151, 18161, 18211, 18241, 18291, 18381, 18411, 18421, 18431, 18441
- 510(k) numbers
- ["K935842"]
- PMA numbers
- not on file
- Product code
- BTR
- Firm FEI
- 3005747797
- Firm city
- Morrisville
- Firm state
- NC
- 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