CLASS I Device recall · Reported 5 Mar 2014 · FDA Enforcement Report
Heart Cath Custom Pack recalled by Medline Industries
Medline Industries is recalling Heart Cath Custom Pack, distributed nationwide in the US. The recall was initiated on 14 Aug 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1048-2014
- FDA event ID
- 66080
- Recalling firm
- Medline Industries, Waukegan, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 14 Aug 2013
- FDA classified
- 21 Feb 2014
- Reported
- 5 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 14 Aug 2013 | Recall initiated by company | |
| 21 Feb 2014 | Classified by FDA | +191 days |
| 5 Mar 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Where it was distributed
Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
Nationwide AlabamaCaliforniaFloridaIllinoisLouisianaOhioVirginia
Questions about this recall
Is Heart Cath Custom Pack recalled?
Yes. Medline Industries recalled Heart Cath Custom Pack on 14 Aug 2013. The recall is Class I and its status is Terminated. Recall number Z-1048-2014.
Why was it recalled?
Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Which lots are affected?
Pack Number: DYNJ39747A; Lots: 13EB2095, 13EB3153, 13FB4157, 13RB0832, 13GB2692
Where was it sold?
Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medline Industries
All 686| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |