| | Class 2 Device Recall Prestige Coil System |  |
| Date Initiated by Firm | May 08, 2025 |
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| Date Posted | June 18, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1989-2025 |
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| Recall Event ID |
96787 |
| 510(K)Number | K220699 |
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| Product Classification |
Device, Vascular, for Promoting Embolization - Product Code KRD
|
| Product | Prestige Coil System REFs/UDI-DI codes:
PRES0153CXPPLT 00810068567311
PRES1045CPKPLT 00810068567663
PRES1245CPKPLT 00810068567694
PRES1445CPKPLT 00810068567724
PRES0103CXPPLT 00810068567304
PRES2512CXPPLT 00810068567397
PRES0258CXPPLT 00810068567380
PRES0212CXPPLT 00810068567373
PRES0204CXPPLT 00810068567342
PRES0206CXPPLT 00810068567359
PRES0208CXPPLT 00810068567366
PRES3520CXPPLT 00810068567441
PRES3530CXPPLT 00810068567458
PRES0310CXPPLT 00810068567403
PRES0320CXPPLT 00810068567410
PRES0420CPKPLT 00810068567489
PRES0517CPKPLT 00810068567519
PRES0540CPKPLT 00810068568028
PRES0620CPKPLT 00810068567557
PRES0635CPKPLT 00810068567564
PRES0650CPKPLT 00810068567571
PRES0720CPKPLT 00810068567588
PRES0735CPKPLT 00810068567595
PRES0750CPKPLT 00810068567601
PRES0830CPKPLT 00810068567618
PRES0845CPKPLT 00810068567625
PRES0153HXPPL 00818053027147
PRES0204HXPPL 00818053029943
PRES0204CXPPL 00818053027321
PRES0208HXPPL 00818053029981
PRES0315HXPPL 00818053027178
PRES0307CXPPL 00818053027376
PRES0420HPKPL 00818053027185
PRES0440HPKPL 00810068567830
PRES0520HPKPL 00818053027192
PRES0540HPKPL 00810068567847
PRES0650HPKPL 00810068567854
PRES0720HPKPL 00818053027215
PRES0750HPKPL 00810068567861
PRES0830HPKPL 00818053027222
The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. |
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| Code Information |
Product Description/Product Catalog Number/UDI-DI/Lot Numbers:
PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800442
PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800505
PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800708
PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800794
PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800513
PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800544
PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800512
PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800538
PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800790
PRES1445CPKPLT Prestige 14mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1445CPKPLT 00810068567724 F230800793
PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800574
PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800575
PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800576
PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800947
PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES2512CXPPLT 00810068567397 F230800549
PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES2512CXPPLT 00810068567397 F230800759
PRES0258CXPPLT Prestige 2.5mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0258CXPPLT 00810068567380 F230800833
PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800515
PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800527
PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800578
PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800791
PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800941
PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800454
PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800546
PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800771
PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800888
PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800479
PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800580
PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800715
PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800938
PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F241100052
PRES0208CXPPLT Prestige 2mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0208CXPPLT 00810068567366 F230800940
PRES0208CXPPLT Prestige 2mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0208CXPPLT 00810068567366 F230800949
PRES3520CXPPLT Prestige 3.5mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3520CXPPLT 00810068567441 F230800418
PRES3520CXPPLT Prestige 3.5mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3520CXPPLT 00810068567441 F230800529
PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800482
PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800483
PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800769
PRES0310CXPPLT Prestige 3mm x 10cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0310CXPPLT 00810068567403 F230800504
PRES0310CXPPLT Prestige 3mm x 10cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0310CXPPLT 00810068567403 F230800763
PRES0320CXPPLT Prestige 3mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0320CXPPLT 00810068567410 F230800441
PRES0420CPKPLT Prestige 4mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0420CPKPLT 00810068567489 F230800795
PRES0420CPKPLT Prestige 4mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0420CPKPLT 00810068567489 F230800796
PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800451
PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800664
PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800797
PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800831
PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F230800822
PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F230800886
PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F241200132
PRES0620CPKPLT Prestige 6mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0620CPKPLT 00810068567557 F230800458
PRES0620CPKPLT Prestige 6mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0620CPKPLT 00810068567557 F230800517
PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800511
PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800519
PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800766
PRES0650CPKPLT Prestige 6mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0650CPKPLT 00810068567571 F230800821
PRES0720CPKPLT Prestige 7mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0720CPKPLT 00810068567588 F230800440
PRES0720CPKPLT Prestige 7mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0720CPKPLT 00810068567588 F230800510
PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800518
PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800537
PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800818
PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230900021
PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800444
PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800509
PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800665
PRES0830CPKPLT Prestige 8mm x 30cm (Ver. T) Prestige Plus Complex Pack PRES0830CPKPLT 00810068567618 F230800516
PRES0845CPKPLT Prestige 8mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES0845CPKPLT 00810068567625 F230800486
PRES0845CPKPLT Prestige 8mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES0845CPKPLT 00810068567625 F230800503
PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0153HXPPL 00818053027147 F230800481
PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0153HXPPL 00818053027147 F230800524
PRES0204HXPPL Prestige Coil 2mm x 4cm Prestige Plus Helical Xtra Pac PRES0204HXPPL 00818053029943 F230800782
PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0204CXPPL 00818053027321 F230800809
PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0204CXPPL 00818053027321 F240501011
PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800863
PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800864
PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800865
PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800879
PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800880
PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800815
PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800890
PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800892
PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F241100535
PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac PRES0307CXPPL 00818053027376 F230800746
PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230800861
PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230800862
PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900036
PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900037
PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900038
PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F241100975
PRES0440HPKPL Prestige Coil 4mm x 40cm Prestige Plus Helical Pack PRES0440HPKPL 00810068567830 F230800889
PRES0440HPKPL Prestige Coil 4mm x 40cm Prestige Plus Helical Pack PRES0440HPKPL 00810068567830 F230800893
PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800438
PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800447
PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800498
PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800704
PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800943
PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F241200129
PRES0540HPKPL Prestige Coil 5mm x 40cm Prestige Plus Helical Pack PRES0540HPKPL 00810068567847 F230800445
PRES0540HPKPL Prestige Coil 5mm x 40cm Prestige Plus Helical Pack PRES0540HPKPL 00810068567847 F230800569
PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800448
PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800467
PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800570
PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800727
PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800810
PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F230800565
PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F240501363
PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F240501600
PRES0750HPKPL Prestige Coil 7mm x 50cm Prestige Plus Helical Pack PRES0750HPKPL 00810068567861 F230800891
PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0830HPKPL 00818053027222 F230800860
PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0830HPKPL 00818053027222 F240501413
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Recalling Firm/
Manufacturer |
BALT USA, LLC
29 Parker Ste 100
Irvine CA 92618-1667
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| For Additional Information Contact | Mr. David Vu
949-788-1443 |
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Manufacturer Reason
for Recall | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. |
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FDA Determined
Cause 2 | Vendor change control |
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| Action | On 05/08/2025, the firm sent via priority mail and an, "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that defect impacting specific lots of the Optima and Prestige Coil Systems, in which the distal 3 cm radiopaque (RO) marker may not be visible under fluoroscopy.
Customers are instructed to:
As a voluntary alternative to returning the affected products, devices from the affected lots can be inspected by trained hospital personnel for the presence of the RO marker using available fluoroscopy imaging equipment prior to a clinical procedure. It is important to conduct this inspection as soon as possible. The image is achieved by taking the fluoroscopic image of the coil system within the unopened box.
1) If the image contains the RO marker, as exemplified from Figure 1,
i. Complete the Notice of Receipt (refer to the annex on page 5) indicating the verified results.
ii. Mark the inspected boxes with the date and time of the fluoroscopy test and the name of the person performing the test.
iii. Return the product back to your inventory with no further action required.
iv. Send the completed Notice of Receipt to Balt USA at QA@baltgroup.com.
2) If the image does not contain the RO marker from Figure 2 or if the RO marker is not visually discernable, contact Balt USA at QA@baltgroup.com to process the return of the product.
If customers desire to return the products:
Distribution agents or Hospital Staff:
-Identify and locate the affected Coil System and cease all use of the affected product(s).
-For returning collect and put in quarantine and then return them to Balt USA through the usual RMA procedure by contacting our Customer Service.
-Contact Balt USA at QA@baltgroup.com or phone +949-788-1443. |
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| Quantity in Commerce | 1754 devices |
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| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WI. The countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Italy, Japan, Jordan, Kazakhstan, Korea, Kyrgyzstan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, and Vietnam. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = KRD
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