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FDA Medical Device Recalls (openFDA)

Medical Components, Inc dba MedComp: Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T

Recall number
Z-0103-06
Recalling firm
Medical Components, Inc dba MedComp
Product
Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T
Status
Terminated
Initiated
2005-09-15
Posted
2005-10-28
Terminated
2005-11-22
Reason
The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F
Root cause
Other
Action
On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product.
Quantity
10 units
Distribution
The products were shipped to distributors in OH and MO.
Lot, serial or model codes
Lot number MABY360
510(k) numbers
["K003682"]
PMA numbers
not on file
Product code
LJS
Firm FEI
2518902
Firm city
Harleysville
Firm state
PA
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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