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FDA Medical Device Recalls (openFDA)

Centurion Medical Products: Tri-State Hospital Supply Corp., Centurion Healthcare Products, Full Term Meconium Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM115.

Recall number
Z-0106-2010
Recalling firm
Centurion Medical Products
Product
Tri-State Hospital Supply Corp., Centurion Healthcare Products, Full Term Meconium Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM115.
Status
Terminated
Initiated
2009-09-22
Posted
2009-11-12
Terminated
2010-08-03
Reason
The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete obstruction of the airway.
Root cause
Process control
Action
The firm's sales representative was notified of the recall on September 22, 2009 via email and the sole customer was notified by letter dated September 23, 2009. All product was removed from the customer account on September 28, 2009 and returned to the recalling firm.
Quantity
750
Distribution
Illinois.
Lot, serial or model codes
Lots 01297, 07097, 09107, 12037, 06028, 2008091501, 2008120801, 2009033001 and 2009062201.
510(k) numbers
not on file
PMA numbers
not on file
Product code
BTR
Firm FEI
1824619
Firm city
Howell
Firm state
MI
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

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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

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